Health Related Quality of Life (HRQOL) in Patients Receiving Chemoimmunotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) or Fludarabine and Cyclophosphamide (FC) for First Line Therapy with Advanced Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3438-3438 ◽  
Author(s):  
Barbara F. Eichhorst ◽  
Kirsten Fischer ◽  
Anna- Maria Fink ◽  
Guenter Fingerle-Rowson ◽  
Anne Westermann ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Research Funding ◽  
Progression Free Survival ◽  
Response Rates ◽  
Global Health Status ◽  
Free Survival ◽  
Baseline Questionnaire ◽  
Hrqol Outcome ◽  
Significant Difference

Abstract Abstract 3438 Poster Board III-326 INTRODUCTION Chemoimmunotherapies like the FCR combination have been shown to increase complete remission rates and progression-free survival in patients with CLL in comparison to chemotherapies without biologicals (Hallek et al., ASH 2008). Until now little is known on HRQOL outcome of CLL patients receiving chemoimmunotherapy. Therefore we assessed the HRQOL in patients with advanced CLL, who were randomized between FC and FCR treatment within an international randomized trial of the German CLL Study Group (GCLLSG). METHODS 817 pts with good physical fitness as defined by a cumulative illness rating scale (CIRS) score of up to 6 and a creatinine clearance (cr cl) ≥ 70 ml/min were enrolled between July 2003 and March 2006. Pts were randomly assigned to receive 6 courses of either FC (N=409; F 25mg/m2 i.v. d1–3 and C 250 mg/m2 i.v. d1–3; q 28 days) or FC plus R (N=408; 375 mg/m2 i.v. d 0 at first cycle and 500 mg/m2 d1 all subsequent cycles; q 28 days). The EORTC C30 questionnaires were sent to all patients included in Germany or Austria at baseline, after 3, 6, 12 months (mo) and then in yearly follow-up (FU). In all other countries questionnaires were handed out to the patients personally on the same time points during their visits in the study center. The analysis of the questionnaires was performed according to the EORTC recommendations (Aaronson et al., 1993). The questionnaire contained a global health scale, five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain, nausea and vomiting) as well as six single items (dyspnea, appetite loss, sleep disturbances, financial impact, constipation and diarrhea). Mean score values of the EORTC scales ranged between 0 and 100. High scores in the functional scales represent good HRQOL, low scores in the symptom scales a low symptom burden. RESULTS HRQOL was evaluated in 763 (93%) of the included patients who completed at least one questionnaire (376 (49%) FC and 387 (51%) FCR treated patients). The compliance rate was significantly higher in those countries, where the questionnaire was handed out personally (96% in other countries versus 92% in Germany and Austria; P=0.013). Pts answering the baseline questionnaire and at least one further questionnaire (444; 58%) were compared to those how did not (319, 42%): pts with only one or a missing baseline questionnaire had a significantly higher CIRS score (1,7 vs 1,4; P=0.007) and more frequently leukocytopenias (24% CTC grade 3 and 4 leukocytopenias vs 13%; P< 0.001). Age, distribution of Binet stages, gender, poor prognostic factors (del(11q) or del(17p), unmutated IgVH) and treatment arms were similar distributed between both groups. There were also no differences in the rate of other toxicities or response rates. A total of 482 questionnaires were available initially, 406 at interim staging, 454 at final staging, 496 after 12 mo FU, 414 after 24 mo FU and 198 after 36 mo FU. A comparison of the two treatment arms at interim or final staging after 3 and 6 months respectively showed no significant difference between both arms with regards to the global health status, functional scales and symptom scales. Dyspnoe was scored significantly higher during FC treatment in comparison to FCR (23 versus 18; P = 0.023). At 12, 24 and 36 months of FU no significant difference between FC and FCR in all functional scales, symptom scales, single item and global health status was found. Both treatment arms showed slight improvement (defined as difference of 5-10 points) of global health status at 12 months FU in comparison to baseline (FC: 62 at baseline vs 68 at FU 12; FCR: 62 vs 70). CONCLUSIONS Although the FCR regimen is associated with a higher rate of cytopenias in patients' perception this increased hematological toxicity does not result in a difference in HRQOL between both treatment arms. After a median observation time of 38 mo the better efficacy of the FCR regimen with regards on response rates and progression-free survival does not yet result in an improved HRQOL. For the final evaluation of HRQOL outcome after chemoimmunotherapy a longer is FU is needed. Disclosures Eichhorst: Roche: Honoraria, Research Funding; Mundipharma: Research Funding; Hospira: Honoraria. Fischer:Roche: Travel Grand; Munipharma: Travel Grand. Fink:Roche: Travel Grand. Fingerle-Rowson:OrthoBiotech: Employment; Roche: Honoraria. Westermann:Roche: Travel Grand. Wendtner:Roche: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; BayerSchering: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Hallek:Roche: Research Funding, Speakers Bureau; Mundipharma: Research Funding, Speakers Bureau.

Impact on quality of life of adding cetuximab to irinotecan in patients who have failed prior oxaliplatin-based therapy: The EPIC trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4003-4003 ◽  
Author(s):  
C. Eng ◽  
J. Maurel ◽  
W. Scheithauer ◽  
L. Wong ◽  
M. Lutz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Global Health Status ◽  
Significant Difference ◽  
Eortc Qlq ◽  
The Impact

4003 Background: EPIC, a multinational phase III clinical trial examined the impact of cetuximab on survival in pretreated EGFR- expressing metastatic colorectal (MCRC) patients (pts). Pts were randomized to either cetuximab 400 mg/m2 followed by 250 mg/m2 weekly and irinotecan 350 mg/m2 q 3 weeks or irinotecan alone. The primary endpoint was overall survival (OS) with quality of life being one of the secondary endpoints. Methods: Health Related Quality of life (HRQoL) of pts in this trial was assessed through the EORTC QLQ-C30 questionnaire, version 3.0. Pts completed the questionnaire pretreatment, every second cycle, and at first follow-up visit. HRQoL was compared between treatment arms using a Wei-Lachin test. Results: Baseline demographics were balanced between the arms. Cetuximab plus irinotecan (n=648) was superior to irinotecan alone (n=650) in progression-free survival (HR 0.69, p<.0001) and response rate (16.4 vs 4.2%, p<.0001). OS was comparable between the arms, but may have been influenced by subsequent therapy: 46% of subjects in the irinotecan alone arm received cetuximab, 89% of them in combination with irinotecan. Baseline HRQoL scores did not significantly differ between treatment arms for 11 of the 15 scales. For 4 scales (Social Functioning, Fatigue, Dyspnea, and Appetite Loss), there were statistically significant differences in baseline scores, in favor of the cetuximab plus irinotecan arm. Non- compliance rates (missing questionnaires) were similar between the arms. A statistically significant difference was noted for pts in the cetuximab plus irinotecan arm in HRQoL on 10 of the 15 scales as compared to patients in the irinotecan arm, with the scores of the cetuximab plus irinotecan arm consistently higher, as noted by the scales of Global Health Status (p=.047), pain (p< .0001), and nausea (p<.0001). Conclusions: In addition to statistically significant improvements in PFS and RR in patients receiving cetuximab plus irinotecan compared with irinotecan alone, HRQoL was better preserved on the combination arm with less deterioration in symptom scores (pain, nausea, insomnia), as well as global health status scores. No significant financial relationships to disclose.

Patient-Reported Quality of Life In Elderly, Newly Diagnosed Multiple Myeloma Patients Treated with Bortezomib-Based Regimens: Results From the Phase 3b UPFRONT Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3026-3026 ◽  
Author(s):  
Ruben Niesvizky ◽  
Ian W. Flinn ◽  
Robert M. Rifkin ◽  
Nashat Y Gabrail ◽  
Veena Charu ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Treatment Period ◽  
Research Funding ◽  
Global Health Status ◽  
Status Score ◽  
Patient Reported ◽  
Equity Ownership ◽  
Eortc Qlq ◽  
Health Status Score

Abstract Abstract 3026 Background: UPFRONT is an ongoing US community-based phase 3b study designed to compare the safety and efficacy of three bortezomib (Velcade®, Vc)-based regimens, Vc-dexamethasone (VcD), Vc-thalidomide-dexamethasone (VcTD), and Vc-melphalan-prednisone (VcMP), followed by Vc maintenance therapy, in previously untreated multiple myeloma (MM) patients who were ineligible for high-dose therapy and autologous stem cell transplantation (HDT-SCT). Efficacy data have been presented elsewhere; here we present patient-reported quality of life (QoL) data after 300 patients had the opportunity to undergo the entire 13-cycle treatment period (8 Vc-based induction cycles and 5 Vc maintenance cycles). Methods: Patients with symptomatic, measurable MM were randomized (1:1:1) to receive 49 weeks of therapy: 24 weeks (eight 21-day cycles) of induction with VcD, VcTD, or VcMP (VcD: Vc 1.3 mg/m2, days 1, 4, 8, 11; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [cycles 1–4]), days 1, 2, 4, 5 [cycles 5–8]); VcTD: Vc 1.3 mg/m2, days 1, 4, 8, 11; T 100 mg/d, d1–21; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [cycles 1–4]), days 1, 2, 4, 5 [cycles 5–8]); VcMP: Vc 1.3 mg/m2, days 1, 4, 8, 11; M 9 mg/m2, and P 60 mg/m2, day 1–4, every other cycle), followed by 25 weeks (five 35-day cycles) of maintenance with Vc alone (1.6 mg/m2, days 1, 8, 15, 22). Patient-reported QoL was recorded using the EORTC QLQ-C30 questionnaire, which assesses global health status, physical, role, cognitive, emotional, and social functions, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Patients completed the questionnaire prior to dosing on cycle 1, day 1 (baseline), prior to dosing on day 1 of every odd cycle, at the end of treatment visit, and every 12 weeks thereafter. Here we present updated study results after 300 patients had the opportunity to undergo the entire 13-cycle treatment period, focusing on change in global health status score over time; no adjustment was made for missing cases or patient deaths. Results: Patient baseline characteristics were well balanced across the three treatment arms. Patients in the VcD, VcTD, and VcMP arms had median ages of 73.5, 73.0, and 72.0 years, respectively; 85%, 64%, and 74% had ISS stage II/III; 22%, 27%, and 28% were non-Caucasian; and 51%/25%/24%, 55%/30%/14%, and 62%/24%/15% had Charlson comorbidity index 0/1/≥2 in the VcD, VcTD, and VcMP arms, respectively. Patients received a median of 9 (VcD), 6 (VcTD), and 7 (VcMP) treatment cycles (induction + maintenance); 56%, 33%, and 43% of patients, respectively, received Vc maintenance. In the VcD, VcTD, and VcMP arms, Vc dose intensity (mean ratio of doses received/doses planned) was 76%, 63%, and 69% during induction, and 73%, 77%, and 85% during maintenance, respectively. After 13 treatment cycles, the rates of grade ≥3 adverse events (AEs) were 74%, 86%, and 80% in the VcD, VcTD, and VcMP arms. The incidence of serious AEs was highest in the VcTD arm (61%, vs 57% and 51% with VcD and VcMP), as was the rate of study drug discontinuation due to AEs (41%, vs 29% and 35% with VcD and VcMP). Global health status score by cycle is shown in the Figure, with number of patients with available QoL data in each arm indicated below. In all three arms, for those patients with available QoL data, global health status score at the end of cycle 12 was greater than at baseline and at the end of cycle 8 (end of Vc-based induction therapy). In the induction phase, global health status score remained stable in the VcD arm and transiently decreased in the VcMP arm at cycle 4, before increasing to above baseline levels. A similar trend was seen for the VcTD arm; global health status score started decreasing at cycle 2 but took slightly longer to increase, possibly due to the increased incidence of AEs in the VcTD arm. Similar trends were seen for other EORTC QLQ-C30 function and symptom scores. Conclusions: Although there was some variability during the study, by the end of the treatment period patients who received one of the three Vc-based regimens reported improvements in QoL compared with baseline values. The study is ongoing and patients continue to be followed for assessment of patient-reported QoL and long-term outcomes. Updated QoL data, including the correlation between change in QoL and best response achieved, will be presented. Disclosures: Niesvizky: Celgene: Consultancy, Research Funding; Millennium Pharmaceuticals, Inc.: Consultancy, Research Funding; Onyx: Consultancy, Research Funding. Off Label Use: Discussion of Velcade in a novel combination in frontline myeloma is included. Flinn:Millennium Pharmaceuticals, Inc.: Research Funding. Rifkin:Millennium Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Speakers Bureau; Amgen: Speakers Bureau; Cephalon: Speakers Bureau; Dendreon: Speakers Bureau. Gabrail:Millennium Pharmaceuticals, Inc.: Research Funding. Charu:Amgen: Equity Ownership, Research Funding; Pfizer: Equity Ownership; GSK: Equity Ownership, Research Funding; Lilly: Equity Ownership, Research Funding; Millennium Pharmaceuticals, Inc.: Research Funding; Roche: Research Funding; Bristol-Myers Squibb: Equity Ownership. Neuwirth:Millennium Pharmaceuticals, Inc.: Employment. Corzo:Millennium Pharmaceuticals, Inc.: Employment. Reeves:Celgene: Equity Ownership.

Tandem Autologous Hematopoietic Stem Cell Transplants (AuHCT) with or without Maintenance Therapy (auto-auto) Versus Single AuHCT Followed by HLA Matched Sibling Non- Myeloablative Allogeneic HCT (auto-allo) for Patients with Standard Risk (SR) Multiple Myeloma (MM): Results From the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0102 Trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 41-41 ◽  
Author(s):  
Amrita Krishnan ◽  
Marcelo C Pasquini ◽  
Marian Ewell ◽  
Edward A. Stadtmauer ◽  
Edwin P Alyea ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Progression ◽  
Board Of Directors ◽  
Research Funding ◽  
Progression Free Survival ◽  
Response Rates ◽  
Advisory Committees ◽  
Free Survival ◽  
Allogeneic Hct ◽  
Matched Sibling

Abstract Abstract 41 AuHCT improves survival in patients with MM, but disease relapse and progression remain a challenge. Both tandem AuHCT and post transplant maintenance therapy improve progression-free survival (PFS). Alternatively, allogeneic HCT has the potential to reduce disease progression through a graft-versus-myeloma effect. Use of nonmyeloablative conditioning regimens allows the latter approach to be used with reduced treatment-related mortality (TRM). BMT CTN 0102 was a multicenter phase III trial that biologically assigned patients with MM to auto-auto using melphalan 200mg/m2 (MEL 200) conditioning or an auto-allo approach using MEL 200 followed by alloHCT with 2 Gy total body irradiation. Graft-versus-disease (GVHD) prophylaxis was cyclosporine and mycophenolate mofetil. The primary endpoint was 3-year progression free survival (PFS). Between December 2003 and March 2007, 710 patients from 43 US centers were enrolled. Patients were assigned to the auto-allo arm based on availability of an HLA-matched sibling donor at time of enrollment. Patients in the auto-auto arm were further randomized to thalidomide and dexamethasone (Thal-Dex) for 1 year or observation (obs). Among 625 patients with SR MM (absence of chromosome 13 deletion by metaphase karyotyping and β-2 microglobulin ≤ 4mg/L), 436 were assigned to auto-auto (217 Thal-Dex, 219 obs) and 189 to auto-allo. Compliance with Thal-Dex was poor, with 84% of patients not completing prescribed therapy. PFS and overall survival (OS) between the Thal-Dex and obs cohorts were equal and these arms were pooled for the primary analysis. The auto-auto and auto-allo groups differed in age (median 55y vs. 52y, p =0.01) and time between first and second transplants (median 98d vs 105d, p =0.02), but were otherwise balanced. Complete and near complete (CR+nCR) response rates at study entry were 24% for both groups. Three-year PFS was 46% and 43% (p=0.67) and 3-year OS was 80% and 77 % (p=0.19) for the auto-auto and auto-allo groups, respectively. Corresponding probabilities for 3-year progression/relapse were 50% and 46% (p=0.8) and for 3-year TRM were 4% and 11% (p=0.04). Among auto-allo patients, probabilities of grade III-IV acute and chronic GVHD were 9% and 47%, respectively. Eighty-two percent of patients in each arm received the assigned second transplant. Among 522 patients who received their second transplant, 3-year PFS was 47% and 44% (p=0.89) with auto-auto and auto-allo, respectively. Disease response rates at day 56 after second HCT were: 50% very good partial response (VGPR) or better and 40% CR+nCR in the auto-auto group; and 49% (VGPR or better, p=0.8) and 48% (CR+nCR,p=0.12) in the auto-allo group. In conclusion, there were no differences in 3-year PFS and OS between patients receiving auto-auto or auto-allo. Potential benefits of graft-versus-myeloma to reduce disease progression or relapse were offset by increased TRM. Thal-Dex maintenance did not improve PFS or OS, likely due to poor tolerability of this regimen. At 3 years, the auto-allo approach for SR MM had no added benefit compared to tandem AuHCT. Disclosures: Krishnan: Celgene: Speakers Bureau. Stadtmauer:Celgene: Speakers Bureau. Comenzo:Millenium Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Elan Pharmaceuticals: Consultancy; Genzyme: Research Funding; Celgene: Research Funding; Ortho: Research Funding. Hari:Celgene: Research Funding. Qazilbash:Celgene: Speakers Bureau. Vesole:Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Giralt:Celgene: Honoraria, Speakers Bureau; Millenium: Honoraria, Speakers Bureau.

Cyclophosphamide, Adriamycin, Vincristine and Prednisone Plus Rituximab (CHOP-R) in Fludarabine (F) Refractory Chronic Lymphocytic Leukemia (CLL) or CLL with Autoimmune Cytopenia (AIC) or Richter's Transformation (RT): Final Analysis of a Phase II Study of the German CLL Study Group

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2860-2860
Author(s):  
Petra Jenke ◽  
Barbara Eichhorst ◽  
Raymonde Busch ◽  
Nadine Anheier ◽  
Ulrich Duehrsen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Ii ◽  
Research Funding ◽  
Progression Free Survival ◽  
Response Rates ◽  
Median Number ◽  
Response Evaluation ◽  
Free Survival ◽  
Richter's Transformation ◽  
Grade 3

Abstract Abstract 2860 Introduction: In the last decade, important progress has been achieved in the treatment of CLL through the use of purine analog-based chemoimmunotherapies. Several conditions remain a challenge, often with a poor outcome. Amongst these therapeutic problems are Richter's transformation (RT), refractoriness to F-based therapies (Fref), and the occurrence of AIC, which are sometimes induced by F. Fref and RT pts have a very poor prognosis with an estimated overall survival (OS) of only 10 and 8 months (mos), respectively. Therefore, therapeutic alternatives are urgently warranted. CHOP-R has improved the outcome of pts with aggressive non-Hodgkin's lymphoma. To test the efficacy and tolerability of the CHOP-R regimen in CLL patients with RT, Fref, or AIC, the GCLLSG initiated a prospective phase II trial. Material and Methods: 62 patients were included in the study. Due to protocol violations, 2 patients were excluded. Within the group of Fref pts, the medical review detected 11 patients who had received pre-treatment with F (Fpret), but were not refractory according to the updated guidelines (Hallek et al., Blood 2008). Thus, 26 pts were classified as Fref/pret, 19 pts as AIC and 15 pts as RT. All patients received CHOP every 3 weeks (cyclophosphamide 750mg/m2, adriamycin 50mg/m2 and vincristine 1, 4mg/m2 d1; prednisone 100mg/m2 d1–5). Rituximab was added starting with the 2nd cycle (375mg/m2 on each d0, and 21 days after the last CHOP-R). RT pts received up to 8, Fref/pret and AIC up to 6 courses of CHOP-R. In case of PD after 3 cycles, pts went off-study. The primary endpoints were remission rate, quality and duration of response. Results: 79%, 73%, and 40% of AIC, Fref/pret, and RT pts were male, respectively. The median age was 65 years (y) for Fref/pret-pts, 66y in the AIC and 69y in the RT group. Binet stages for Fref/pret pts were: A: 8%; B: 27% C: 65 %. All but 3 AIC pts were at Binet stage C. Initial RT stages according to Ann Arbor were: II: 13%, III: 13%, IV 73%. The median number of previous therapies were 3 for Fref/pret, 2 for AIC and 2 for RT. A total of 314 cycles were administered, with a median number of 3 cycles for AIC and Fref pts and a median number of 4 cycles for the RT group. Due to toxicity 73% of cycles in the Fref/pret group, 66% in the AIC and 87% in the RT group were dose-reduced. 69% of Fref/pret-pts and 58% of AIC-pts received full 6 cycles of therapy and only 40% of RT-pts completed 8 cycles of therapy. Treatment was stopped in 6 pts because of PD. Due to treatment related toxicity treatment was stopped in 16 pts (27%). Treatment related mortality was 3% (2 pts). Treatment toxicity was reported according to NCI common toxicity criteria (CTC) version 2.0. Adverse events grade 3 or 4 for anemia, neutropenia and thrombocytopenia were documented in 75%, 55% and 65% of patients, respectively. Infections were the most common non-hematologic toxicity and occurred in 67%; severe infections CTC grade 3 or 4 occurred in 28%. All 26 Fref/pret-pts were available for response evaluation. CHOP-R achieved 54% PR, 35% SD and 12% PD. The median progression-free survival (PFS) and median treatment-free survival (TFS) were 11 and 14 mos. OS was 27 mos with a significant difference concerning F-ref (n=15) and F-pret (n=11) pts (17 vs. 35m; p=0.05). We evaluated the response of all 15 RT-pts with 60% PR, 7% CR, 13% SD and 20% PD. The PFS was 15 mos, TFS was 17 mos and OS 27 mos. 17 AIC pts were available for response evaluation with 82% PR, 6% SD and 12% PD. The PFS and TFS were only 14 and 16 mos. The OS was 50 mos. The population had a high incidence of unfavourable genetic markers: deletion of chromosome 17p [del(17p)] was detected in 24%, del(11q) in 34% and unmutated IGHV in 70%. 85% had high levels of serum thymidine kinase (sTK > 10 U/l), and 49% had high levels of ß2-microglobulin (ß2M > 3.5 mg/l). Patients with del(17p) had an unfavourable response rate and achieved significant less a PR or CR (36% vs. 76%; p=0.03). Multivariate analyses showed that del(17p) and ECOG performance status had a negative prognostic impact on OS (p<0.0001). Moreover the presence of a del(17p) predicted a short PFS (6 vs. 16.9 mos; p=0.001). Conclusion: CHOP-R achieves promising response rates in CLL patients with Fref and RT and very good response rates in patients with AIC. However, the progression-free survival and overall survival remain unsatisfactory. Therefore, CHOP-R might be used as induction therapy prior to allogeneic stem cell transplantation in physically fit patients. Disclosures: Eichhorst: Hoffmann La Roche: Honoraria, Research Funding, Travel Grants; Mundipharma: Research Funding, Travel Grants; Gilead: Consultancy. Dreyling:Roche: Research Funding, Scientific advisory board, Speakers Bureau. Bergmann:Celgene: Honoraria. Stilgenbauer:Hoffmann La Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Travel Grants. Fink:Hoffmann La Roche: travel grants. Fischer:Hoffmann La Roche:. Wendtner:Hofmann-La Roche: Consultancy, Honoraria, Research Funding. Hallek:Roche: Consultancy, Honoraria, Research Funding; Mundipharma: Research Funding; Celgene: Honoraria.

scholarly journals Follow-up Analysis of Ixazomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Routine Clinical Practice

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2716-2716
Author(s):  
Jiri Minarik ◽  
Jakub Radocha ◽  
Alexandra Jungova ◽  
Jan Straub ◽  
Tomas Jelinek ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Research Funding ◽  
Previous Analysis ◽  
Progression Free Survival ◽  
Routine Clinical Practice ◽  
Toxicity Profile ◽  
Advisory Committees ◽  
Free Survival ◽  
Significant Difference

Abstract Background: The addition of ixazomib to the doublet lenalidomide and dexamethasone (RD) in relapsed and refractory multiple myeloma (RRMM) has shown significant benefit in progression free survival (PFS) in the TOURMALINE-MM1 study. Several real-world data including our previous analysis confirmed that the combination IRD is feasible and with fair outcomes even outside the clinical trial. Here we report an updated analysis which is aimed at overall survival (OS) and the PFS2 interval which is defined as the time from the date of treatment initiation to the date of first documentation of progressive disease after initiation of further anti-myeloma treatment or death from any cause. Methods: We analyzed a cohort of 344 patients with RRMM, 127 being treated by IRD and 217 by RD combination. The group characteristics and study design are described elsewhere. 1 The median follow-up of the whole cohort was 28.5 months. The primary endpoint was OS, OS in patients with relapse 1-3, progression free survival (PFS), and PFS2. Secondary endpoints were response rates and toxicity profile. For statistical analysis we used Fisher's exact test or Mann-Whitney U test. Survival measures were assessed using the Kaplan-Meier methodology, and statistical significance was assessed using the log-rank test at a significance level of α = 0.05 (all tests two-sided). Results: The outcomes of OS in the whole cohort were already published before, with significantly longer median OS in the IRD vs RD cohort (mOS 36.6 months vs 26.0 months, p = 0.008).1 In the follow-up analysis, the medians were slightly improved, maintaining a significant difference (mOS 40.9 vs 27.1 months, p = 0.001). In patients treated within relapse 1-3, the results outcomes were even more pronounced (mOS 51.7 vs 27.8 months, p ˂ 0.001). The median PFS was also better in the IRD cohort (mPFS 17.5 vs 12.5 months, p = 0.013) but the results did not substantially differ from our previous analysis. The median PFS2 in the IRD vs RD cohort was significantly longer in the IRD cohort (mPFS2 29.8 vs 21.6 months, p = 0.016). The subsequent therapy included mostly pomalidomide (27.5% vs 30.8%), bortezomib (28.8% vs 28.2%) or thalidomide (10.0% vs 16.2%). Monoclonal antibodies (daratumumab, isatuximab) were more frequently used after IRD combination (21.3% vs 4.3%). The response rates in the IRD vs RD cohort were similar as in our primary analysis: overall response rate (ORR) 73.0% vs 66.8%, with significant difference in very good partial response and better (VGPR+) 38.1% vs 26.3%. The toxicity profile did not reveal any additional safety concerns. Majority of grade 3+ toxicities included hematological toxicity (anemia, neutropenia, thrombocytopenia) and infections, with similar distribution in the cohorts. Conclusion: The treatment of RRMM using the full oral IRD regimen in routine clinical practice is easy, safe and with significantly improved outcomes in comparison to RD doublet. Our follow-up analysis confirmed the impact on OS in patients in the whole cohort including relapse 1-3. The median PFS2 was also longer in the IRD cohort, possibly affected by more frequent use of monoclonal antibodies in the next treatment. With support of AZV 17-29343A, NV18-03-00500, MH CZ - DRO (FNOl, 00098892), IGA-LF-2021-001. 1) Minarik J, Pika T, Radocha J. et al. Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice. BMC Cancer 2021; 21: https://doi.org/10.1186/s12885-020-07732-1 Disclosures Minarik: Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria. Hajek: Novartis: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Pharma MAR: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Quality of life and safety profile of pemetrexed-platinum doublet in Indian adult chemo-naive NSCLC patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19118-e19118
Author(s):  
Vikram Gota ◽  
Krunal Vasant Kavathiya ◽  
Damodaran S E ◽  
Amit Joshi ◽  
Vanita Noronha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Locally Advanced ◽  
Global Health Status ◽  
Significant Difference ◽  
Nsclc Patients ◽  
The Impact ◽  
Platinum Doublet

e19118 Background: Pemetrexed in combination with cisplatin or carboplatin is commonly recommended for the first-line treatment of patients with locally advanced or metastatic NSCLC of adenocarcinoma histology. The present study explores the safety and the impact of this doublet on the quality of life in adult Indian NSCLC patients. Methods: Patients were enrolled from a single tertiary care cancer hospital in India. Patients were administered pemetrexed 500 mg/m2, cisplatin 75 mg/m2or carboplatin AUC 5 every 3 weekly. All patients received standard folate and Vitamin B12 supplementation. Premedication included dexamethasone, granisetron and ranitidine. Quality of Life (QoL) data was collected at baseline and at completion of 3 cycles using EORTC QLQ-C30 (version 3) and QLQ- LC13 questionnaires. Toxicity was graded using CTCAE v. 4.03. Results: Twenty seven patients were enrolled on the study since July 2012.Twenty received carboplatin and seven received cisplatin. Mean age of the participants was 54.7 years (SD=9.58) with stage (IV=25; III A/B=2) and ECOG performance status (0=1; 1=17; and 2=9). Pemetrexed–platinum doublet caused significant improvement in Global Health Status and dyspnea score at 3 cycles compared to baseline (Table). The treatment also caused marked improvement in the physical function, emotional function, cognitive function and insomnia scales, although not statistically significant (Table). No significant difference compared to baseline was observed for other parameters. Grade 3/4 toxicities include anemia (3), neutropenia (3), hyponatremia (6), vomiting), diarrhea, and dyspnea (1 each). Conclusions: Pemetrexed-platinum doublet was well tolerated and markedly improved the global health status and dyspnoea at the end of three cycles. A higher incidence of hyponatreemia was observed in our cohort that needs to be investigated further. [Table: see text]

177Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel: Updated results including progression-free survival (PFS) and patient-reported outcomes (PROs) (TheraP ANZUP 1603).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 6-6
Author(s):  
Michael S Hofman ◽  
Louise Emmett ◽  
Shahneen Kaur Sandhu ◽  
Amir Iravani ◽  
Anthony M. Joshua ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Objective Response ◽  
Progression Free Survival ◽  
Global Health Status ◽  
Castration Resistant Prostate Cancer ◽  
Promising Alternative ◽  
Clinical Endpoints ◽  
Point Reduction ◽  
Patient Reported

6 Background: TheraP is a randomized phase 2 trial that showed LuPSMA significantly improved the primary endpoint of PSA≥50% reduction (66% vs. 37%) compared to cabazitaxel in men with docetaxel-treated mCRPC. We now report results on other clinical endpoints and PROs reached the pre-specified target of 170 PFS events. Methods: 200 men with mCRPC (median age 72 y, prior enza/abi 91%) and high PSMA-expression by 68Ga-PSMA-11 and no sites of FDG-positive/PSMA-negative disease, were randomly assigned (1:1) to LuPSMA (6-8.5GBq q6wk up to 6 cycles; N = 99) or cabazitaxel (20mg/m2 q3wk up to 10 cycles; N = 101). Secondary endpoints include PSA/radiologic PFS (PCWG3), pain response (≥2 point reduction on McGill-Melzack Present Pain Intensity scale, objective response rate (ORR) (RECIST 1.1), adverse events (CTCAE), PROs (EORTC QLQ-C30) and overall survival (OS). Cut-off date for analysis of 20JUL20. Results: At a median follow-up of 18.4 months, PFS was significantly longer in those assigned Lu-PSMA rather than cabazitaxel (rates at 1y 19% [95%CI 12-27%] vs 3% [1-9%], hazard ratio (HR) 0.63, 95%CI 0.46-0.86; p = 0.003; 173 events). Similar benefit was seen for rPFS (HR 0.64, 95%CI 0.46-0.88; p = 0.007; 160 events) and PSA-PFS (HR 0.60 95%CI 0.44-0.83; p = 0.002; 172 events). ORR in 78 men with measurable disease was significantly greater in the LuPSMA arm (49% vs 24%, RR 2.1, 95%CI 1.1-4.1; p = 0.019). In 90 men with pain at baseline, pain responses occurred in 60% in the Lu-PSMA arm vs 43% for cabazitaxel (RR 1.42, 95%CI 0.84-4.48; p = 0.10). Patient-reported global health status was similar (LuPSMA 64 [95%CI 61-67] vs cabazitaxel 60 [57-64]) with significantly better outcomes reported for fatigue (34 [95%CI 31-37] vs 40 [36-43]), social functioning (79 [76-82] vs 73 [69-77]), insomnia (24 [20-27] vs 29 [25-33]) and diarrhoea (8.3 [5.6-11.0] vs 15.6 [12.6-18.6]) domains. No PRO domains were superior for cabazitaxel. G3-4 AEs were similar to previously reported (33% vs 53%). OS data remains immature (90 deaths). Conclusions: In men with docetaxel-treated mCRPC, LuPSMA is a promising alternative to cabazitaxel with significantly higher activity (PSA≥50%, PFS, ORR), fewer G3-4 AEs, similar effects on global health status, and improvements in some PRO domains. Clinical trial information: NCT03392428.

Health-Related Quality of Life Impairment in Patients with Chronic Myeloid Leukemia: Results of a German Cross-Sectional Study of Patients Registered in Prospective, Controlled Clinical Trials

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2773-2773 ◽  
Author(s):  
Susanne Saussele ◽  
Mareike Stein ◽  
Arthur Gil ◽  
Ute Kossak-Roth ◽  
Michael Lauseker ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Cognitive Functioning ◽  
Research Funding ◽  
Cross Sectional Study ◽  
Global Health Status ◽  
German Population ◽  
Cross Sectional ◽  
Travel Grant ◽  
Advisory Role

Abstract Introduction: With many treatment options for chronic myeloid leukemia (CML), endpoints like health-related quality of life (HRQoL) move into focus and might be essential for deciding on treatment strategies. We sought to evaluate HRQoL in CML patients who had been registered in four consecutive studies of the German CML study group. Methods: The EORTC QLQ-C30 questionnaire was used to assess HRQoL of CML patients. Functional scales and global health status were calculated in accordance with Aaronson (1993) and Fayers (2001). With scales ranging from 0 to 100, 8 points are regarded as a minimally important difference (Efficace et al., 2013). Baseline data of responders (R) and non-responders (NR) were compared. Associations between two variables were assessed by the Fisher or Mann-Whitney tests, as appropriate. The global health status and the functioning scores were compared between groups with the van Elteren test, if the groups were stratified for another variable. Furthermore, results of the global health status and the functioning scores in our sample were standardized in accordance with the age (18-29, 30-39, 40-49, 50-59, 60-69, ≥70 years) and sex distribution of the 2448 participants of the German HRQoL outcome study reported by Hinz et al. 2014. The outcome of our sample was then compared with the outcome of these 2448 patients representing QoL of the German population in general. Comparison was performed using a t test. Results: A questionnaire was sent to 1634 patients. During January to April 2011, 858 questionnaires (53%) were sent back. Compared to NR, R were older (median age: 55 vs. 58, p=0.0426); years since diagnosis (median 6.5 vs. 7.4) and the percentage that had been transplanted were lower (24%vs.18%). No differences were observed regarding sex, Euro score, or time after allogeneic hematopoietic stem cell transplantation (HSCT). When answering the questionnaire, 517 (60%) patients received imatinib 400mg (IM400) and 102 (12%) were off therapy after HSCT. Less than 10% of patients received imatinib 800mg, imatinib+AraC or interferon alpha, nilotinib, or dasatinib. Time since diagnosis was ≤3 years in 156 (18%), >3 and ≤7 years in 309 (36%), and >7 years in 393 (46%) of the patients. Women (352, 41%) perceived a significant reduction in global health status (mean: 62.7, p<0.001), role (65.4, p=0.0016), emotional (60.3, p=0.0002), and physical functioning (74.9, p<0.0001) when compared to males (68.9, 71.5, 67.6, and 82.7, respectively). In the latter two cases, this perception met the definition of a clinical relevance. Results on significance did not change with adjustment for age. Compared to the German population, the 858 CML patients had significantly lower scores for global health status (mean: 67.9, p<0.0001), role (70.8, p<0.0001), social (69.2, p<0.0001), emotional (64.6, p<0.0001), physical (81.0, p<0.0001) and cognitive functioning (77.3, p<0.0001). Only for global health status, the difference was below 8. To evaluate HRQoL in patients with long standing disease, 100 patients with diagnosis >7 years off therapy after HSCT and 203 patients receiving IM400 were analyzed. Adjusted for age group and sex, CML patients receiving IM400 for more than 7 years had lower scores for global health status (mean: 63.8, p<0.0001 ), role (66.7, p<0.0001), social (68.8, p<0.0001), emotional (64.0, p<0.0001), physical (75.2, p<0.0001) and cognitive functioning (68.0, p<0.0001) than the German control population. With respect to all six HRQoL scores, significantly lower scores than from the German population were also observed for the CML patients being seven years without treatment after HSCT: global health status (mean: 69.2, p<0.0001 ), role (68.6, p<0.0001), social (67.5, p<0.0001), emotional (68.1, p<0.0001), physical (83.1, p<0.0001) and cognitive functioning (71.2, p=0.0053). Conclusions: In this cross-sectional study, women showed an impaired global health status, role, emotional, and physical functioning compared to males. Considering all 858 CML patients, the HRQoL was significantly impaired in all scales when compared to the German population. The same results were observed for the subgroups of patients either receiving IM400 for at least 7 years or being off therapy 7 years after HSCT. Reduced HRQoL remains an issue for all patients after long-term TKI treatment or after HSCT. These data may serve as a basis to evaluate HRQoL in stopping studies in CML. Disclosures Saussele: BMS: Honoraria, Other: Travel grant, Research Funding; Novartis Pharma: Honoraria, Other: Travel grant, Research Funding; ARIAD: Honoraria; Pfizer: Honoraria, Other: Travel grant. Kremers:Novartis: Honoraria; Bristol Myers Squibb: Other: Travel costs, supporting educational meeting; Novartis: Other: supporting educational meeting. Hochhaus:Bristol-Myers Squibb: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; ARIAD: Honoraria, Research Funding. Müller:BMS: Honoraria, Other: Consulting or Advisory Role, Research Funding; Novartis: Honoraria, Other: CONSULTING OR ADVISORY ROLE, Research Funding; ARIAD Pharmaceuticals Inc.: Honoraria, Other: Consulting & Advisory Role, Research Funding. Hehlmann:Novartis Pharma: Research Funding; BMS: Consultancy. Pfirrmann:BMS: Consultancy, Honoraria; Novartis Pharma: Consultancy, Honoraria.

scholarly journals Health-Related Quality of Life in Adults with B-Cell Precursor Acute Lymphoblastic Leukemia and Minimal Residual Disease Treated with Blinatumomab

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1377-1377 ◽  
Author(s):  
Ralf C Bargou ◽  
Gerhard Zugmaier ◽  
Massimiliano Bonifacio ◽  
Carlos Graux ◽  
Christoph Faul ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
B Cell ◽  
Social Functioning ◽  
Research Funding ◽  
Residual Disease ◽  
Lymphoblastic Leukemia ◽  
Global Health Status ◽  
Cell Precursor ◽  
Support Research

Abstract Background: Positive minimal residual disease (MRD) is an established prognostic marker for hematologic relapse, negative hematopoietic stem cell transplantation (HSCT) outcome, and mortality in adults with B-cell precursor acute lymphoblastic leukemia (ALL; Gökbuget N, et al. Blood. 2012;120:1868-1876). In the open-label, single-arm phase 2 BLAST study (N=116; ClinicalTrials.gov, NCT01207388), treatment with blinatumomab, a bispecific T-cell engager (BiTE®) antibody construct that redirects cytotoxic T cells to residual CD19+ blast cells, led to complete MRD response in 88 of 113 (78%) patients after cycle 1 (Gökbuget N, et al. Blood. 2018;131:1522-1531). Median overall survival was 36.5 months. Among patients with Philadelphia chromosome-negative B-cell ALL in complete MRD remission, relapse-free survival was 54% at 18months. In this analysis of the BLAST study, we assessed the health-related quality of life (HRQoL) of patients during and after treatment with blinatumomab. Methods: Eligible patients (≥18 years) had B-cell precursor ALL in first or later hematologic complete remission and persistent or recurrent MRD ≥10-3 after ≥3 blocks of intensive chemotherapy. Blinatumomab 15 μg/m2/day was administered by continuous intravenous (cIV) infusion for 4 weeks, followed by a 2-week infusion-free interval, for up to 4 cycles. Patients could receive HSCT any time after cycle 1. HRQoL was assessed using the EORTC QLQ-C30 Questionnaire at baseline, on day 29 of each treatment cycle, at the safety follow-up visit (30 days after end of treatment), and at the efficacy follow-up visits (3, 6, 9, 12, 18, and 24 months after treatment start). The questionnaire included 1 global health status scale, 5 functioning scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single-symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For global health status and functioning scales, a higher score indicates better HRQoL; for symptom scales/items, a lower score indicates better HRQoL. A 10-point change is often viewed as the minimum clinically important difference (MID) in EORTC QLQ-C30 (Zikos E, et al. EORTC, 2016). In this analysis, the mean (SD) and the mean (SD) change from baseline to end of cycle 1 of the scores for each scale/item was summarized at each scheduled assessment during and after blinatumomab treatment. Results: In total, 89 patients had a nonmissing baseline value and a nonmissing value of any scale on day 29 of cycle 1, and thus were evaluable for HRQoL. The patient-reported global health status and functioning scale scores were stable over time during and after blinatumomab treatment (Figure 1). Symptom-scale and single-symptom scores were similarly stable during and after treatment (not shown). Mean (SD) changes from baseline to end of cycle 1 in global health status and in physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning were 2.5 (18.5), 0.3 (12.5), -4.0 (30.0), 4.2 (20.5), -1.7 (16.2), and 10.4 (31.8), respectively (Figure 2). These results show that, after 1 cycle of blinatumomab, the change in HRQoL was minimal for most scales, with potential clinically meaningful improvements in social functioning. Similar minimal changes were observed for all symptom scales/items (not shown). Conclusions: In this population of patients with B-cell precursor ALL and MRD successfully treated with blinatumomab 15 μg/m2/day cIV for up to 4 cycles, HRQoL was maintained during and after blinatumomab treatment, which is an important result considering the potential HRQoL impact of standard chemotherapy. Disclosures Zugmaier: Amgen Inc.: Consultancy, Employment, Patents & Royalties: 20170327581, 9688760, 20170122947, 9486475, 20160208001, 9192665, 20150071928, 8840888, 20140227272, 20140228316, 20130323247, 20130287774, 20130287778, 20110262440, 20100112603, 7700299, 20070037228. Bonifacio:Incyte: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; Novartis: Research Funding; Bristol Myers Squibb: Consultancy. Topp:Boehringer Ingelheim: Research Funding; Regeneron Pharmaceuticals, Inc.: Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Research Funding. Tran:Amgen Inc.: Employment. Zhang:Amgen Inc.: Employment, Equity Ownership. Goekbuget:Kite / Gilead: Consultancy; Celgene: Consultancy; Novartis: Consultancy, Other: Travel support, Research Funding; Pfizer: Consultancy, Other: Travel support, Research Funding; Amgen: Consultancy, Other: Travel support, Research Funding.

TPExtreme randomized trial: Quality of Life (QoL) and survival according to second-line treatments in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6507-6507 ◽  
Author(s):  
Joel Guigay ◽  
Jerome Fayette ◽  
Ricard Mesia ◽  
Esma Saada-Bouzid ◽  
Cedrik Lafond ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Global Health Status ◽  
Open Label ◽  
Trial Quality ◽  
Significant Difference ◽  
Health Status Score

6507 Background: TPExtreme trial comparing EXTREME regimen to the taxane-based TPEx confirmed the encouraging survival results of the TPEx regimen, despite lack of significant overall survival (OS) increase, with a significantly lower toxicity than the EXTREME regimen. Herein, the QoL and exploratory analyses of survival according to 2nd line treatments focusing on immunotherapy (IO) are presented. Methods: Randomized (1:1), open-label trial. Main inclusion criteria were R/M HNSCC not suitable for loco-regional treatment, age 18-70 years, PS < 2, creatinin clearance > 60ml/min, prior cisplatin < 300 mg/m². 539 pts were enrolled over a period of 37 months (mo). QoL was evaluated with QLQ-C30 questionnaire at baseline, week(W)12, W18, W26 and analyzed by linear mixed model. The primary QoL endpoint was the Global Health Status score. 2nd line treatments were collected for 501 (93%) patients (pts), 256 in the EXTREME arm and 245 in the TPEx arm. Results: The percentage of QLQ-C30 questionnaires filled at baseline, W12, W18 and W26 were similar in the 2 arms, 89%, 52%, 43%, and 39% in the EXTREME arm and 91%, 59%, 40%, and 37% in the TPEx arm, respectively.. Higher scores of Global Health Status (p = 0.02), physical functioning (p = 0.009) and role functioning (p = 0.013) and lower scores of appetite loss (p = 0.041) were observed in the TPEx arm than in the EXTREME arm. No significant difference was observed for the other scores. In 2nd line treatment, 120 (47%) pts in the EXTREME arm and 109 (44%) in the TPEx arm received chemotherapy +/- cetuximab (CT); 41 (16%) pts in the EXTREME arm and 41 (17%) in the TPEx arm received IO, mainly anti-PD-1/PD-L1. 79% and 85% of these 2nd line treatments were given after progression in EXTREME and TPEx arms respectively. Median OS (95%CI) since randomization was 17.6 (15.2 – 19.5) mo with CT and 19.4 (13.4 – 22.3) mo with IO in the EXTREME arm vs 14.9 (13.0 – 16.3) and 21.9 (15.9 – 35.0) mo in the TPEx arm (interaction test p = 0.077) respectively. Median OS since start of 2nd line was 9.3 mo with CT and 8.3 mo with IO in the EXTREME arm, and 7.1 and 11.6 mo respectively in the TPEx arm. Conclusions: An improvement in the QoL of patients was observed in the TPEx arm compared to that of the EXTREME arm. Exploratory analysis showed that the taxane-based TPEx regimen followed by IO in 2nd line could provide interesting median OS for pts who need CT in 1st line, with less toxicity than EXTREME. This sequential treatment deserves to be compared to a strategy that starts with Platinum+5FU+pembrolizumab. Clinical trial information: NCT02268695 .

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