Randomized phase II comparison of standard CHOP with weekly CHOP in elderly patients with non-Hodgkin's lymphoma.

1995 ◽  
Vol 13 (9) ◽  
pp. 2386-2393 ◽  
Author(s):  
R M Meyer ◽  
G P Browman ◽  
M L Samosh ◽  
A M Benger ◽  
D Bryant-Lukosius ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Elderly Patients ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Dose Intensity ◽  
Intermediate Grade ◽  
Ecog Performance Status ◽  
Standard Regimen ◽  
And Performance

PURPOSE To determine whether modifying the standard regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) from full doses given every 3 weeks to one-third doses given weekly (chop) increases the received chemotherapy dose-intensity in elderly patients with advanced-stage intermediate-grade lymphoma. PATIENTS AND METHODS Consenting patients, age > or = 65 years who had acceptable cardiac, renal, and liver function and an Eastern Cooperative Oncology Group (ECOG) performance status less than 4, were stratified by bone marrow and performance status and randomized to receive standard CHOP or weekly chop. Drug doses were attenuated or escalated according to a defined dose-modification schedule. The primary outcome was average relative received dose-intensity. Secondary outcomes included response, progression-free and overall survival, toxicity, and performance status. RESULTS Nineteen patients were allocated to each group. No difference in received dose-intensity was seen. When dose-intensity was calculated for the first six cycles of therapy, average relative received dose-intensity was .92 with CHOP versus .89 with weekly chop (P = .5); when calculated for the first 18 weeks of therapy, values were .88 with CHOP versus .89 with weekly chop (P = .8). The complete response rate was 68% with CHOP versus 74% with weekly chop (P = .9). At 2 years, the progression-free survival rate was 57% with CHOP versus 46% with weekly chop (P = .16) and the survival rate was 74% with CHOP versus 51% with weekly chop (p = .05). More myelotoxicity was seen with CHOP. CONCLUSION We conclude that CHOP can be given in sufficient doses to elderly patients and that weekly chop does not increase received dose-intensity. Progression-free and overall survival are unlikely to be superior with weekly chop, and may be worse. CHOP should remain the standard against which new therapies for elderly patients with intermediate-grade lymphoma are compared.

Survival Comparison Amongst Commonly Used Frontline Regimens in Patients Age 70 Years and Older with Acute Myeloid Leukemia (AML): A Single-Institution Study of over 600 Patients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2505-2505 ◽  
Author(s):  
Varun C Dhulipala ◽  
Martine Extermann ◽  
Najla Al Ali ◽  
Jongphil Kim ◽  
Marina Sehovic ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
Supportive Care ◽  
High Intensity ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Pairwise Comparison ◽  
Ecog Performance Status ◽  
Treatment Groups ◽  
Low Intensity

Abstract Introduction Treatment of elderly patients with acute myeloid leukemia (AML) is a therapeutic challenge. Elderly patients frequently have more biologically inherent resistant disease, along with comorbidities that together result in poor overall survival (OS). Optimal frontline therapy for elderly patients with AML remains controversial, and choice of regimen varies among clinicians. In this large, single-institution retrospective cohort study of AML patients over age 70, we present survival analysis and comparison amongst a variety of commonly used initial regimens. Methods 602 AML patients aged 70 or greater who received treatment between 1995 and 2014 in a single-large institution were retrospectively analyzed. Patients were categorized into 4 different treatment groups: High Intensity Therapy (defined as daunorubicin/cytarabine or equivalent), Hypomethylating Agent (HMA) Therapy, Low intensity Therapy (defined as low-dose cytarabine or similar without HMAs), and Supportive Care (including hydroxyurea if indicated). Age, type of AML, history of previous hematological disease, cytogenetics, ECOG performance status, comorbidities (Charlson Index), complete blood counts and blast percentage at time of diagnosis were obtained for each treatment category. Pairwise comparison of survival between different treatment groups was performed, using the stratified log-rank test and propensity score matching to adjust for potential treatment indication bias between groups. Within pairwise comparison groups, the stratified Cox proportional hazards regression model was used to assess correlation of the clinical variables with overall survival. Results Median age was 77 years (range 70 - 95) with a male predominance (M:F=68%:32%). ECOG Performance Status was 0 to 1 in 80% and 2 to 4 in 20% of patients. Per NCCN criteria, cytogenetics risk category was intermediate or favorable in 67% and unfavorable in 33%. Baseline median WBC, hemoglobin and platelet counts were 3.31 k/uL, 9.40 g/dL and 43 k/uL respectively. Median baseline bone marrow blast percentage was 35% (range 2% - 95%), and the large majority (445 of 550 patients - 81%) had peripheral blood blasts at the time of diagnosis. The majority of patients had secondary AML (61%) compared with de novo AML (39%). Of those with secondary AML, myelodysplastic syndrome (MDS) was the most common antecedent hematologic disease (97%), for which 36% had received prior HMAs. For frontline therapy, 238 (40%) patients received High Intensity Therapy; 110 (18%) received HMA Therapy, 67 (11%) received Low Intensity Therapy, and 187 (31%) received Supportive Care. Pairwise comparison between HMA Therapy and the 3 other treatment groups individually demonstrated statistically significant superior OS with HMA Therapy (median 13.3 mo; 95% CI 10.6 - 16.8 mo) compared to High Intensity Therapy (median 9.5 mo; 95% CI 7.4 - 10.9 mo), Low Intensity Therapy (median 5.9 mo; 95% CI 4.2 - 7.8 mo) and Supportive Care (median 2.5 mo; 95% CI 2.1 - 3.0 mo.). In addition, pairwise comparisons demonstrated superior OS with high vs low-intensity (p=0.0007), but no significant difference between Low-Intensity and Supportive Care (p=0.10). A pairwise comparison between HMA and High Intensity Therapy in the small subset of patients who had received prior HMA for MDS revealed extremely poor outcomes in both arms, with < 6 month median OS. Conclusion In this analysis of a very large data set of patients over age 70 with AML, using pairwise comparison with propensity score matching, our results indicate a survival benefit with high intensity therapy or HMAs compared to supportive care or low-intensity (non-HMA) therapy. Interestingly, treatment with HMAs also resulted in better OS than traditional high intensity therapy. These data are contributing to an ongoing effort to design a comprehensive decision analysis model comparing treatment effectiveness according to baseline characteristics in AML patients 70 and older. Figure 1. Overall Survival Amongst Treatment Groups Figure 1. Overall Survival Amongst Treatment Groups Disclosures Lancet: Kalo-Bios: Consultancy; Boehringer-Ingelheim: Consultancy; Celgene: Consultancy, Research Funding; Amgen: Consultancy; Seattle Genetics: Consultancy; Pfizer: Consultancy.

scholarly journals Comparison of the Freiburg and Charlson Comorbidity Indices in Predicting Overall Survival in Elderly Patients with Newly Diagnosed Multiple Myeloma

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Sung Min Kim ◽  
Moon Jin Kim ◽  
Hyun Ae Jung ◽  
Kihyun Kim ◽  
Seok Jin Kim ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Elderly Patients ◽  
Performance Status ◽  
Solid Cancer ◽  
Newly Diagnosed ◽  
History Of ◽  
Comorbidity Index ◽  
And Performance ◽  
The Impact

Multiple myeloma occurs primarily in elderly patients. Considering the high prevalence of comorbidities, comorbidity is an important issue for the management of myeloma. However, the impact of comorbidity on clinical outcomes has not been fully investigated. We retrospectively analyzed patients with newly diagnosed myeloma. Comorbidities were assessed based on the Charlson comorbidity index (CCI) and the Freiburg comorbidity index (FCI). The CCI is a summary measure of 19 comorbid conditions. FCI is determined by performance status, renal impairment, and lung disease. This study included 127 patients with a median age of 71 years. Approximately half of the patients had additional disorders at the time of diagnosis, and diabetes mellitus was the most frequent diagnosis (18.9%). The most significant factors for prognosis among patient-related conditions were a history of solid cancer and performance status (ECOG ≥ 2). The FCI score was divided into 3 groups (0, 1, and 2-3), and the CCI score was divided into 2 groups (2-3 and ≥4). FCI was a strong prognostic tool for OS (P>0.001) and predicted clinical outcome better than CCI (P=0.059). In conclusion, FCI was more useful than CCI in predicting overall survival in elderly patients with myeloma.

Longitudinal cumulative dose: A novel measure to assess multiple dimensions of chemotherapy adherence over time.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3522-3522
Author(s):  
Michael Webster-Clark ◽  
Alexander P Keil ◽  
Hanna Kelly Sanoff ◽  
Til Sturmer ◽  
Daniel Westreich ◽  
...  
Keyword(s):  
Cumulative Dose ◽  
Standard Dose ◽  
Performance Status ◽  
Dose Intensity ◽  
International Study ◽  
Standard Regimen ◽  
Number Of Patients ◽  
And Performance ◽  
The Impact ◽  
Over Time

3522 Background: Adjuvant chemotherapy regimens take months to complete. Despite this, trials and observational studies evaluate chemotherapy adherence via measures assessed at the end of treatment (e.g. number of patients missing any dose, relative dose intensity [RDI]). This approach misses information that impacts outcomes, like treatment delays. We propose longitudinal cumulative dose (LCD) as a way to integrate the impact of dose reductions, missed doses, and dose delays at each cycle over time. Methods: We obtained data from the 2,246 participants in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer (MOSAIC). We evaluated proportions of patients stopping treatment early and reducing (based on protocol), missing, or delaying a dose in each arm for each chemo agent at each visit. We obtained LCD, the fraction of the final standard dose a participant reached by a given day, for each participant and each chemo agent. We compared LCD medians over time and at the end of a standard regimen (24 weeks) between treatment arms and by age and performance status. We assessed agreement between oxaliplatin LCD and RDI with Fleiss’ kappa (Table). Results: Participants randomized to FOLFOX were more likely than those randomized to 5FU to stop treatment, reduce doses, miss doses, or delay visits; these differences increased over time. Median LCD for oxaliplatin in the FOLFOX arm at 24 weeks was 77%. Graphs of median LCD for 5FU showed a clear difference between arms (FOLFOX arm median LCD: 81%; 5FU arm median LCD, 96%). While 5FU LCD decreased with age in the FOLFOX arm (median LCD in those age <40: 85%; 40-64, 82%; 65-75, 76%), it was similar across ages in the 5FU arm (median LCD 94%, 96%, and 96%, respectively), with smaller performance status trends. RDI and LCD showed fair agreement (Fleiss’ kappa=0.34); 19% of those with RDI over 85% had LCD under 60%. Conclusions: Visualizing LCD highlighted the timing and scale of deviations from standard administration, with major differences in 5FU LCD across arms. Next steps include evaluating if LCD predicts clinical outcomes. [Table: see text]

scholarly journals A Phase II Study of Docetaxel in Chemotherapy-Naïve Patients With Recurrent or Metastatic Adult Soft Tissue Sarcoma

Sarcoma ◽  
1998 ◽  
Vol 2 (1) ◽  
pp. 29-33 ◽  
Author(s):  
Vivien Bramwell ◽  
Martin Blackstein ◽  
Karl Belanger ◽  
Shail Verma ◽  
Sandra Beare ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Haematological Toxicity ◽  
Dose Intensity ◽  
Ecog Performance Status ◽  
Metastatic Soft Tissue Sarcoma ◽  
Toxicity Criteria

Purpose:To determine the efficacy and toxicity of docetaxel as first-line chemotherapy in adult patients with locally advanced and/or metastatic soft tissue sarcoma (STS).Patients/methods.Thirty eligible patients, with histologically proven STS, Eastern Cooperative Oncology Group (ECOG) performance status 0–2 and bidimensionally measurable disease, entered this study. None had received previous chemotherapy. Docetaxel 100 mgm−2was given as a 1-h intravenous infusion every 3 weeks. Patients were evaluable for response, evaluated by WHO criteria, after one cycle of chemotherapy and toxicity was graded by NCIC-CTG common toxicity criteria.Results.One hundred and thirty two cycles were aldministered, with a range per patient of 1–9. The median delivered dose intensity was 32.2 mgm−2 week−1(planned 33.3 mgm−2 week−1) and 67% of patients received ≥90% planned dose intensity. There were three partial responses (10.7%; 95% confidence interval 2.3–28.2) with a median duration of 7 months (range 6.4–8.3 months). Thirty patients were evaluable for non-haematological toxicity and 28 for haematological toxicity (repeat counts were not available in two patients). Haematological toxicity was moderately severe, with 18 (64%) patients experiencing at least one episode of grade 4 neutropenia, and 7 (25%) patients experiencing febrile neutropenia.Conclusions.In this study, activity of docetaxel in adult chemotherapy-naïve patients with advanced STS was modest

scholarly journals Regorafenib in Recurrent Glioblastoma Patients: A Large and Monocentric Real-Life Study

Cancers ◽  
2021 ◽  
Vol 13 (18) ◽  
pp. 4731
Author(s):  
Giuseppe Lombardi ◽  
Mario Caccese ◽  
Marta Padovan ◽  
Giulia Cerretti ◽  
Giovanna Pintacuda ◽  
...  
Keyword(s):  
Overall Survival ◽  
Life Experience ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Methylation Status ◽  
Eastern Cooperative Oncology Group ◽  
Real Life ◽  
Recurrent Glioblastoma ◽  
Ecog Performance Status ◽  
Life Study

Despite multimodal treatment with surgery and radiochemotherapy, the prognosis of glioblastoma remains poor, and practically all glioblastomas relapse. To date, no standard treatment exists for recurrent glioblastoma patients and traditional therapies have showed limited efficacy. Regorafenib is an oral multi-targeted tyrosine kinase inhibitor showing encouraging benefits in recurrent GBM patients enrolled in the REGOMA trial. We performed a large study to investigate clinical outcomes and the safety of regorafenib in a real-life population of recurrent glioblastoma patients. Patients receiving regorafenib outside clinical trials at the Veneto Institute of Oncology were retrospectively reviewed. The major inclusion criteria were: histologically confirmed diagnosis of glioblastoma, prior first line therapy according to “Stupp protocol”, Eastern Cooperative Oncology Group (ECOG) performance status score ≤1. According to the original schedule, patients received regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle. The primary endpoints of the study were overall survival and safety. A total of 54 consecutive patients were enrolled. The median age was 56, MGMT methylated status was found in 28 out of 53 available patients (52.8%), IDH mutation in 5 (9.3%) and 22 patients were receiving steroids at baseline. The median overall survival was 10.2 months (95% CI, 6.4–13.9), the OS-12 was 43%. Age, MGMT methylation status and steroid use at baseline were not statistically significant on a multivariate analysis for OS. Patients reporting a disease control as best response to regorafenib demonstrated a significant longer survival (24.8 months vs. 6.2 months for patients with progressive disease, p = 0.0001). Grade 3 drug-related adverse events occurred in 10 patients (18%); 1 patient (2%) reported a grade 4 adverse event (rash maculo-papular). No death was considered to be drug-related. This study reported the first large “real-life” experience of regorafenib in recurrent glioblastoma. Overall, our results are close to the ones reported in the previous phase 2 study, despite the fact that we had a longer survival. We showed the encouraging activity and tolerability of this treatment in recurrent glioblastoma patients when used as a second-line treatment.

A multi-institutional feasibility study of S-1/oxaliplatin (SOX) plus bevacizumab in patients with advanced/metastatic colorectal cancer: HiSCO-02 prospective phase II study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 728-728
Author(s):  
Manabu Kurayoshi ◽  
Katsunori Shinozaki ◽  
Takao Hinoi ◽  
Tsuyoshi Kobayashi ◽  
Manabu Shimomura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Dose Intensity ◽  
Sensory Neuropathy ◽  
Standard Regimen ◽  
Promising Alternative

728 Background: mFOLFOX6 regimen, which is a standard regimen for metastatic colorectal cancer (CRC), is inconvenient owing to its requirement for continuous infusion via vascular access. We aimed to investigate the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab, a promising alternative treatment to replace mFOLFOX6. Methods: We undertook a clinical phase II trial in 12 institutions in Hiroshima, Japan. We enrolled individuals aged 20–80 years who had metastatic CRC, had an Eastern Cooperative Oncology Group performance status (PS) of 0 or 1, had assessable lesions, and had received no previous chemotherapy. Eligible patients were assigned SOX plus bevacizumab (S-1: 80-120 mg/body/day, day 1–14 orally administrated, oxaliplatin: 130mg/m2 day 1 i.v., bevacizumab: 7.5mg/kg day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary end points were progression-free survival (PFS), overall survival (OS), and safety. Results: From May 2011 to January 2014, 55 patients (mean age, 64 years) were enrolled. The number of metastatic organs were one: 29 cases (52.7%), two or more: 25 cases (45.4%), and 2 cases had no target lesions (3.6%). Median follow up time was 12.8 months (range, 1.4-38.6 months). RR was 45.4% (95% CI, 32.2%-58.6%) and disease control rate was 87.3% (95% CI, 78.5-96.1%). Median PFS and OS time were 9.2 months (95% CI, 7.6-10.8) and 22.0 months (95% CI, 17.7-26.2), respectively. The median number of cycles of chemotherapy was 7 (range, 1-16). The median relative dose intensity of oxaliplatin, S-1, and bevacizumab were 85%, 85%, and 87%, respectively. Major toxic effects (grade 3/4) were thrombocytopenia (5.7%), neutropenia (7.5%), sensory neuropathy (13.2%), and anorexia (17.0%). Conclusions: These data indicated that the SOX plus bevacizumab regimen is effective and well tolerated in patients with metastatic CRC. Clinical trial information: UMIN000004976.

Irinotecan in Combination With Fluorouracil in a 48-Hour Continuous Infusion As First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Spanish Cooperative Group for the Treatment of Digestive Tumors Study

2005 ◽  
Vol 23 (15) ◽  
pp. 3545-3551 ◽  
Author(s):  
Javier Sastre ◽  
Eugenio Marcuello ◽  
Bartomeu Masutti ◽  
Matilde Navarro ◽  
Silvia Gil ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Elderly Patients ◽  
Metastatic Colorectal Cancer ◽  
Continuous Infusion ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Response To Treatment

Purpose Elderly patients constitute a subpopulation with special characteristics that differ from those of the nonelderly and have been underrepresented in clinical trials. This study was performed to determine the efficacy and safety of irinotecan (CPT-11) in combination with fluorouracil (FU) administered as a 48-hour continuous infusion twice a month in elderly patients. Patients and Methods Patients ≥ 72 years old with metastatic colorectal cancer, Eastern Cooperative Oncology Group performance status of 0 to 1, no geriatric syndromes, and no prior treatment were treated every 2 weeks with CPT-11 180 mg/m2 plus FU 3,000 mg/m2 in a 48-hour continuous infusion. Results By intent-to-treat analysis, in 85 assessable patients, the objective response rate was 35% (95% CI, 25% to 46%), and stable disease was 33% (95% CI, 23% to 44%). Median time to progression was 8.0 months (95% CI, 6.0 to 10.0 months), and median overall survival time was 15.3 months (95% CI, 13.8 to 16.9 months). Toxicity was moderate. Grade 3 and 4 neutropenia, diarrhea, and asthenia were observed in 21%, 17%, and 13% of patients, respectively. Only one case of neutropenic fever occurred. There were two toxic deaths, one was a result of grade 4 diarrhea and acute kidney failure, and the other was a result of massive intestinal hemorrhage in the first cycle. The study of prognostic factors did not reveal any predictive factor of response. Response to treatment and baseline lactate dehydrogenase were the main factors conditioning progression-free and overall survival. Conclusion Twice a month continuous-infusion CPT-11 combined with FU is a valid therapeutic alternative for elderly patients in good general condition.

Safety and efficacy of nab-paclitaxel (nab-P)–based therapy in patients (pts) with non-small cell lung cancer (NSCLC) and performance status (PS) 2: Results from ABOUND.PS2.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9058-9058 ◽  
Author(s):  
Ajeet Gajra ◽  
Nagla Abdel Karim ◽  
Deborah A. Mulford ◽  
Liza Cosca Villaruz ◽  
Marc Ryan Matrana ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Dose Intensity ◽  
Primary Analysis ◽  
Median Percentage ◽  
Safety And Efficacy ◽  
Toxicity Risk ◽  
And Performance ◽  
Ecog Ps

9058 Background: Chemotherapy can benefit pts with advanced NSCLC with poor Eastern Cooperative Oncology Group (ECOG) PS, despite an increased toxicity risk vs those with good PS. Safety and efficacy of nab-P/carboplatin ( nab-P/C) induction followed by nab-P monotherapy in pts with advanced NSCLC and ECOG PS 2 are reported. Methods: Chemotherapy-naive pts with histologically/cytologically confirmed stage IIIB/IV NSCLC and ECOG PS 2 received 4 cycles of nab-P 100 mg/m2 d 1, 8 + C AUC 5 d 1 q3w. Pts without disease progression were eligible for monotherapy with nab-P 100 mg/m2d 1, 8 q3w until progression/unacceptable toxicity. Primary endpoint: percentage of pts discontinuing within the first 4 cycles due to treatment-emergent adverse events (TEAEs). Other endpoints: PFS, DCR, OS, ORR, and QoL. Results: Forty pts were treated during the first 4 cycles. Median age was 67.5 y, 60.0% were male, 92.5% were white, and 65.0% had nonsquamous histology. In the primary analysis, 9/40 pts (22.5%) discontinued due to TEAEs during induction. In total, 16/40 pts (40.0%) received nab-P as monotherapy. At the time of data cutoff, 4/40 pts remained on therapy beyond 11 cycles. In all treated pts, the median percentage of per-protocol dose of nab-P was 79.8% and the median nab-P dose intensity was 53.2 mg/m2/week (expected, 66.67 mg/m2/week). See table for other key safety and efficacy data. QoL by LCSS (global) was improved during the study, and similarly EQ-5D-5L dimensions were stable/improved at least once in the majority of pts. Conclusions: This nab-P–based regimen was well tolerated in PS 2 pts with advanced NSCLC. Efficacy outcomes are comparable with previous chemotherapy data with promising QoL. The results support the efficacy and tolerability of this regimen in these pts. NCT02289456. Clinical trial information: NCT02289456. [Table: see text]

Randomized Comparison of ACVBP and m-BACOD in the Treatment of Patients With Low-Risk Aggressive Lymphoma: The LNH87-1 Study

2000 ◽  
Vol 18 (6) ◽  
pp. 1309-1315 ◽  
Author(s):  
Hervé Tilly ◽  
Nicolas Mounier ◽  
Pierre Lederlin ◽  
Josette Brière ◽  
Brigitte Dupriez ◽  
...  
Keyword(s):  
Group Performance ◽  
Remission Rate ◽  
Performance Status ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Tumor Burden ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Standard Regimen

PURPOSE: To compare a short intensified regimen followed by sequential consolidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, cyclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressive lymphoma. PATIENTS AND METHODS: A total of 752 patients with intermediate- or high-grade lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, ≥ two extranodal sites of disease, tumor burden ≥ 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt’s or lymphoblastic subtypes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. RESULTS: The complete remission rate was identical (86%) in the two groups. With a median follow-up duration of 7 years, the 5-year failure-free survival (FFS) rate was 65% in the ACVBP group and 61% in the m-BACOD group (P = .16). The 5-year overall survival rate was 75% in the ACVBP group and 73% in the m-BACOD group (P = .47). ACVBP was responsible for more severe and life-threatening infections (P < .01), but m-BACOD caused more pulmonary toxicity (P < .001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP was associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. CONCLUSION: In this population of patients with low-risk aggressive lymphoma, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regimen in patients with advanced disease is suggested by this analysis but remains to be assessed in prospective studies specifically designed for this purpose.

Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 71-71
Author(s):  
Azim Jalali ◽  
Hui-Li Wong ◽  
Rachel Wong ◽  
Margaret Lee ◽  
Lucy Gately ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Febrile Neutropenia ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

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