Palliative chemotherapy in head and neck cancers: A tertiary care center experience with weekly paclitaxel and cetuximab.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16028-e16028
Author(s):  
Kumar Prabhash ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
Vijay Patil ◽  
S Juvekar ◽  
...  
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Single Agent ◽  
Haematological Toxicity ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Outpatient Setting ◽  
Weekly Paclitaxel ◽  
Best Response ◽  
Grade 3

e16028 Background: The concept of combination of paclitaxel and cetuximab is an intersesting prospect as both these agents have single agent acitivity, minimal toxicity and hold a biological rationale for combination. The aim of our study was to see the safety,efficacy and feasibility of administration of this combination in a outpatient setting. Methods: This was a retrospective analysis of the prospectively collected data, of patients offered weekly paclitaxel and cetuximab from May 2010-May 2011. The standard schedule of cetuximab along with 80 mg/m2 of weekly paclitaxel was administered till either disease progression or withdrawl of patient's consent. The toxicity profile was noted in accordance with CTCAE version 4.02 and response in accordance with RECIST criteria. SPSS version 16 has been utilized for analysis. Descriptive statistics are been presented and analyis of estimation of overall and progression free survival has been done with Kaplan-Meier survival method. Results: 42 patients with a median age of 52 years (35-81 years) were included. The KPS score was 60 in 1 (2.4%),70 in 11 (26.2%) and 80 in 30 patients(71.4%). Nearly half of our patients 22 (52.4%) had a primary in oral cavity. Except 3 (7.1%) patients rest all had received some form of previous treatment. The median event free period(EFP) from previous first line treatment was 231 days, it was below 180 days in 38.5% of patients. Best response observed was CR in 1 patient (2.4%), PR in 11 (26.2%), SD in 17 (40.5%) and PD in 13 (30.9%). Grade 3-4 skin changes were seen in 3 patients, grade 3-4 neuropathy was seen in 3 patients and there were no episodes of grade 3-4 gastrointestinal or haematological toxicity. The overall estimated median PFS and OS were 128 and 256 days. The median estimated PFS for patients with EFP less than 6 months versus more than 6 months was 115 and 165 days respectively (p = 0.132). Conclusions: The combination of paclitaxel and cetuximab was found to be safe, feasible and appears to be clinically beneficial.

Weekly paclitaxel and capecitabine in HER2-negative metastatic breast cancer (MBC): A multicenter GINECO randomized phase II comparing two paclitaxel-capecitabine schedules

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1114-1114
Author(s):  
A. Lortholary ◽  
A. C. Hardy-Bessard ◽  
T. Bachelot ◽  
P. Dalivoust ◽  
G. de Rauglaudre ◽  
...  
Keyword(s):  
Triple Negative ◽  
Haematological Toxicity ◽  
Metastatic Breast ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Treatment Interruption ◽  
Weekly Paclitaxel ◽  
Hormone Receptor Positive ◽  
Combination Methods

1114 Background: Paclitaxel (Ta) and capecitabine (Xel) are synergistic in vitro. Compared to a continuous weekly Tax combined with a classical 14 days (d)/21 Xel administration (Elza-Brown et al., ASCO 2000), we have explored the combination of Xel 5d/week (wk) and weekly Ta 3 wk out 4 in the objective to increase the efficacy/toxicity ratio of the TaXel combination. Methods: Patients (pts) in first or second-line of MBC, previously treated with anthracyclins + docetaxel were randomized either to A: Ta (60 mg/m2/w) + Xel (2000 mg/m2/d x 14 d/21) or to B: Ta (80 mg/m2/w) + Xel (2000 mg/m2/d x 5 d/wk) 3wk out 4. Results: From January 2006 to January 2008, 130 pts were accrued (A 66, B 64). Pts characteristics were well balanced between the two arms including median age (58 yrs), histologic type and grade, hormone receptor-positive tumor (80%), previous treatment, visceral disease (72%), number of sites (>1; 63%), ECOG PS (0; 42%, 1; 58%). Pts received a median of 6 cycles (1–23) with a received/planned mean dose of 89.3% for Ta in both arms and of 74 and 76% for Xel respectively in arm A and B. Haematological toxicity (Tox) was low in both arms with neutropenia Gr 3 in only 8% of cycles, G-CSF support in 2% of cycles, and infection G3 in 5 pts. Alopecia G2 was less frequent in arm A (29 vs 60%). Other Tox were similar in both arms: [G2/3 (%) cutaneous (35/17), pain (36/9), fatigue (26/13), neuropathy (20/3), diarrhea (15/6), mucositis (8/2), vomiting (9/1)] but treatment interruption due to Tox was more frequent in A (A 19, B 7 pts) (p = 0.02). Response rate was 52% (B) versus 44% (A). A progression-free survival advantage was seen for B over A (366 vs 272 days, p = 0,15) including in the triple negative pt subset (n = 26 pts) (197 vs 150 days, p = 0.07). Conclusions: The intermittent regimen (3 wk out 4) of weekly paclitaxel and capecitabine 5 d/week is a well accepted, safe and effective TaXel schedule and might be a chemotherapy regimen of choice in MBC including triple negative patients. No significant financial relationships to disclose.

Prospective analysis of microRNA 31-3p (miR31-3p) as a predictive biomarker of response to anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibodies (mABs) in patients with metastatic colorectal cancer (mCRC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 548-548
Author(s):  
Gayathri Anandappa ◽  
Andrea Lampis ◽  
David Cunningham ◽  
Kyriakos Kouvelakis ◽  
Khurum Khan ◽  
...  
Keyword(s):  
Single Agent ◽  
Growth Factor Receptor ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Predictive Biomarker ◽  
Liquid Biopsies ◽  
Logistic Regression Models ◽  
Best Response ◽  
Ras Status ◽  
Pre Treatment

548 Background: RAS status in tissue and/or liquid biopsies and tumour location (sidedness) are predictive markers of patients’ response to anti-EGFR mABs. MiR-31-3p expression has been correlated with clinical benefit from anti-EGFR mABs with chemotherapy. We aimed to validate the predictive power of miR-31-3p in a prospective cohort of chemo-refractory mCRC patients treated with single agent anti-EGFR mABs in the PROSPECT-C trial (NCT02994888). Methods: MiR-31-3p was tested by in-situ hybridization in 91 pre-treatment (PT) core biopsies from 45 mCRC patients. Sequential tissue biopsies obtained PT, at time of best response and at disease progression were tested to monitor changes in miR-31-3p expression over treatment. In 34 patients miR-31-3p, gender, sidedness, previous lines of treatment and RAS status in PT cell free (cf) DNA were evaluated in multivariate Cox and logistic regression models. Results: Patients with low miR-31-3p expression in PT biopsies showed better overall response rate (ORR: 58.3% vs 22.2%), median progression free survival (mPFS: 4.21 vs 2.27 months) and overall survival (mOS: 4.21 vs 2.27 mo) compared to those with high miR-31-3p expression (Hazard Ratio for PFS high vs low: 1.96; 95% CI: 0.98-3.88; p: 0.06 and HR for OS high vs low: 2.14; 95% CI: 1.04- 4.40; p: 0.04) adjusting for age, gender and sidedness. There was significant association between ORR and miR-31-3p expression (χ2 test p: 0.029). MiR-31-3p expression was an independent predictor of response, adjusting for gender, previous treatment lines and RAS (odds ratio: 0.14; 95% CI: 0.02-1.00, p: 0.048). A trend towards improved mPFS (5.10 vs 2.27 mo) and mOS (15.23 vs 4.67 mo) was noted in miR31-3p low vs high group in cfDNA RAS wild-type patients. No significant change in miR-31-3p expression were observed in archival tissue and sequential tissue biopsies. Conclusions: Our study validates the role of miR-31-3p as potential predictive biomarker of selection for anti-EGFR mABs. Further studies are needed to test if miR-31-3p combined with cfDNA RAS test can identify best responders in specific clinical niches.

Weekly vinblastine in chemotherapy-naive children with unresectable or progressive low grade glioma: A Canadian cooperative study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10029-10029 ◽  
Author(s):  
Eric Bouffet ◽  
Katrin Scheinemann ◽  
Shayna M. Zelcer ◽  
Juliette Hukin ◽  
Beverley Wilson ◽  
...  
Keyword(s):  
Response Rate ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Neurofibromatosis Type ◽  
Low Grade ◽  
Free Survival ◽  
Best Response ◽  
Response To Chemotherapy ◽  
Grade 3

10029 Background: Vinblastine has shown promising activity in a phase II study in children with recurrent/refractory LGG. The aim of this study was to assess the activity of vinblastine in chemotherapy naïve children. Methods: Patients < 18 years old with unresectable or progressive LGG were eligible if they had not received any previous treatment with chemotherapy or radiation. Vinblastine was administered weekly at a dose of 6 mg/m2over a period of 70 weeks. Patients who showed progression on 2 consecutive imaging studies or evidence of clinical progression were removed from treatment. Results: 54 patients (23 female) were enrolled between 2007 and 2010. Median age at inclusion was 7 years, 13 patients were < 3 years. 32 had chiasmatic/hypothalamic tumours, 6 had evidence of dissemination. 13 had neurofibromatosis type 1. Histology was pilocytic astrocytoma (25), pilomyxoid astrocytoma (4), low grade astrocytoma variant (8); 17 patients had no histological diagnosis. Treatment was well tolerated; however, only 14 patients received full dose for the duration of the study. Most common toxicity was haematological: 40 patients who experienced grade 3+ neutropenia. There were only 6 episodes of febrile neutropenia, 3 RBC transfusions and no toxic death. Best response to chemotherapy was assessed centrally by an independent radiologist: 1 CR, 10 PR, 3 MR, 28 SD, 12 PD, for a response rate of 24.5%. With a median follow-up of 2 years (9-48 months), progression-free survival at 2 years was 72.1% (95%CI: 58.1-82.2). One patient died of progression. Conclusions: Weekly vinblastine is well tolerated in paediatric LGG patients. Although the response rate appears inferior to other common LGG regimens, progression free survival at 2 years favourably compares to most currently used regimens. Supported by a grant from the Ontario Institute Cancer Research. Clinical trial information: 1000011227.

Single agent of apatinib in patients with recurrent or refractory cervical cancer: A real-world multicenter retrospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17011-e17011
Author(s):  
Ning Li ◽  
Ziyi Wang ◽  
Jing Wang ◽  
Lingying Wu
Keyword(s):  
Cervical Cancer ◽  
Retrospective Study ◽  
Single Agent ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Medical Sciences ◽  
Cancer Hospital ◽  
Hand Foot Syndrome ◽  
Grade 3

e17011 Background: Few effective treatment strategy has been established for patients with recurrent or refractory cervical cancer. The present study evaluates the efficacy and safety of apatinib single agent in Chinese patients with recurrent or refractory cervical cancer. Methods: Records of patients with cervical cancer treated from October 1, 2016 to December 31, 2017 in Cancer Hospital, Chinese Academy of Medical Sciences and Hunan Cancer Hospital were reviewed. Patients who met the following criteria were included: 1) patients had pathologically confirmed cervical cancer; 2) patients who experienced progression within 6 months or during previous treatment; 3) patients were given 250 mg apatinib daily for the present recurrence; 4) medical records were complete for evaluation of efficacy and toxicity. Tumor response was determined according to RECIST 1.1. The toxicity was determined according to CTCAE 4.0. SPSS 20.0 was adopted for statistic analysis. The primary endpoint was progression-free survival (PFS). Results: Twenty-nine patients were enrolled in our retrospective study. The clinical characteristics were shown in table 1. Thirteen patients (44.8%) had persistent disease and the other 16 patients (55.2%) had recurrent disease less than 6 months after the last treatment. Up to February 1, 2018, the median follow-up time was 8 months. Five (17.2%) patients achieved partial response, and 11 (37.9%) achieved stable disease, representing a disease control rate of 55.1%. The median PFS was 4 months (1-16 months). Nine patients were still on medication. The reasons of discontinued intervention were disease progression (80.0%, 16/20), toxicity (10.0%, 2/20) and other events unrelated with apatinib (10.0%, 2/20). Common adverse events were hypertension (G1, 65.5%), mucositis (G1, 55.2%), hand-foot syndrome (G1-2, 44.8%) and proteinuria (G1-2, 20.7%). Grade 3 proteinuria occurred in 1 patient (3.4%,). Conclusions: Apatinib single agent might be an effective and tolerable choice for patients with recurrent or refractory cervical cancer. Further study is warranted.[Table: see text]

Results of GROC-rev salvage regimen: Gemcitabine, rituximab, and oxaliplatin chemotherapy with revlimid for relapsed/refractory aggressive non-Hodgkin lymphoma (NHL).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7556-7556 ◽  
Author(s):  
Fernando Cabanillas ◽  
Idalia Liboy ◽  
Alexis Cruz ◽  
Pedro Gil Solivan ◽  
Noridza Rivera ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Single Agent ◽  
Progression Free Survival ◽  
Salvage Regimen ◽  
Free Survival ◽  
Non Hodgkin Lymphoma ◽  
Best Response ◽  
Grade 3 ◽  
Clinical Trial Information

7556 Background: Currently there is no optimal salvage regimen for relapsed/refractory NHL (R/R NHL). Prognosis of pts who fail to achieve CR to salvage therapy is dismal. We sought to improve the CR rate by adding Lenalidomide (L) to GROC (ASCO #8530, 2008). Methods: Primary endpoint was rate of conversion to CR after switch to L for pts whose best response to GROC was <CR. Secondary endpoint was progression free survival (PFS) of all pts as well as those who achieve <CR on chemotherapy and were crossed over to L.Pts who failed to achieve at least PR after GROC x2 and those who didn’t achieve CR after GROC x6, were crossed over to L 25 mg x 3 weeks q 28 days. CRs were maintained on L x 2 yrs. Results: 34 pts were enrolled of which 32 are evaluable. Median age: 61 and 56% males. Histologies included DLBCL (81%), PTCL (9%), follicular grade 3-B (9%). Stage was III-IV in 75% and median IPI=2. Best overall response rate (ORR) at any point during treatment= 19/32 (59%) and CR 13/32 (41%). ORR before crossover to L=13/32 (41%) and CR= 8/32 (25%). There were 24 who failed to achieve CR on GROC (19 who didn’t respond at all and 5 whose maximum response was PR). Of these, 21 crossed over to L and 7 (33%) responded (CR in 5, PR in 2). The fact that 5 pts attained a CR to L thus improving the CR rate from 25% to 41% after exhibiting refractoriness to GROC is noteworthy. Of the 7 responders to L, all are alive and only 1 relapsed. At 2 yrs., overall survival (OS) was 48% and PFS 35%. This compares favorably with our previous GROC study without L in which 2 yr. OS= 33% and PFS 29%. In total, 11 pts were eligible for ASCT after chemo plus L and 8 were transplanted (3 refused). Of these eight, 6 remain in CR at 11, 18, 21, 22, 52, 74 mos. At 2 yrs, PFS for transplanted pts is 73% and for those whose response to GROC before crossover to L was <CR, it is 27 mos. Toxic events included 2 neutropenic fevers, 1 MDS (34 mos. after ASCT) and 1 AML (11 mos. after ASCT). Both of these remain continuously in CR after allo SCT. Conclusions: 2 yrOS=48% and PFS=35% with GROC-Rev are the best observed with any salvage regimen we have tested. L is active as a single agent in 29% of cases whose best response to GROC was <CR. A larger study is desirable to confirm these data. Clinical trial information: NCT01307592.

Alternate Day Actimid™ (CC-4047) Is Well Tolerated and Is Active When Used to Treat Relapsed/Refractory Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 332-332 ◽  
Author(s):  
Matthew Streetly ◽  
Kylie Gyertson ◽  
Majid Kazmi ◽  
Jerome Zeldis ◽  
Steve A. Schey
Keyword(s):  
Phase I ◽  
Median Time ◽  
Phase I Study ◽  
Progressive Disease ◽  
Nk Cell ◽  
Single Agent ◽  
Haematological Toxicity ◽  
Maximum Tolerated Dose ◽  
Best Response ◽  
Grade 3

Abstract Actimid™ (CC-4047[Celgene]) is a thalidomide derivative that induces apoptosis, disrupts myeloma-stromal cell adhesion, reduces cytokine secretion, is anti-angiogenic and stimulates anti-myeloma NK cell proliferation. In vivo T-cell and NK cell stimulatory cytokines are enhanced. We have reported a phase I study of daily Actimid with a MTD of 2 mg daily and have carried out a further phase I study using alternate day dosing. Methods: Patients (pts) with relapsed/refractory myeloma who had received at least one prior line of therapy were eligible.This was a dose escalation study designed to define the maximum tolerated alternate day (a/d) dose (1mg, 2mg, 5mg, 10mg). Pts discontinued therapy after 4 weeks if grade 3/4 non-haematological toxicity developed, grade 4 haematological toxicity had not resolved or there was progressive disease. Pts who relapsed following response were eligible to receive dexamethasone (20 mg od for 4 days alternate weeks). Results: 20 pts were treated with median age 58 years (range 34 – 75) and a median of 4 (range 1 – 7) prior lines of chemotherapy (including HDT(65%) and/or thalidomide (85%)). 3/20 pts developed grade 4 neutropaenia within 4 weeks of treatment. All were receiving 10mg a/d. This resolved in all pts within 5 weeks without recourse to growth factors and therapy was restarted at a lower dose. There were no dose limiting grade 3/4 non-haematological toxicities. The maximum tolerated dose was identified as 5 mg a/d. One patient was withdrawn from treatment following the development of relapsing /remitting fevers of unknown origin. He had previously had similar symptoms following treatment with bortezomib. One patient was withdrawn following the development of transverse myelitis and one patient withdrew consent within two weeks of commencing treatment. No pts withdrew due to recurrent neutropaenia. The median duration of exposure to single agent actimid is 5 months (1 – 14) and the overall median duration of therapy is 10 months (1 – 21). All 20 pts are evaluable for response. With a median follow-up of 12 months 12(60%) achieved at least a 25% paraprotein reduction. 19 achieved a best response of stable disease(SD) or better. 1/20 pts progressed within 4 weeks of starting therapy. 2/20 pts attained a complete response, 8/20 pts achieved at least 75% paraprotein reduction (VGPR+CR), 10/20 pts achieved a > 50% paraprotein reduction and a further 2/20 pts achieved a 25 – 50% paraprotein reduction. 6/20 pts had dexamethasone added. Two pts achieved a best response after the addition of dexamethasone (both had relapsed following PR and SD respectively and both achieved VGPR). Additionally 1/6 pts achieved MR and 3/6 pts achieved SD. In the group overall the median time to achieve maximum response was 4 months (1 – 17). 8/20 progressed on treatment with a median time to progression of 10 months (1 – 21). 5/20 pts have subsequently died due to progressive disease. There have been no treatment related deaths. Conclusions: Actimid is a well tolerated oral agent with activity in myeloma. The maximum tolerated dose was 5mg a/d. No grade 3/4 non-haematological toxicity was observed and the neutropaenia resolved rapidly. Responses were excellent with 50% patients achieving at least a 50% reduction in paraprotein. Dexamethasone improved response in 2/6 patients. This study indicates that Actimid has good anti-myeloma activity either as a single agent or in combination with dexamethasone and further clinical studies are justified.

Outcomes in patients (pts) aged ≥65 years in the phase 3 ASCENT study of sacituzumab govitecan (SG) in metastatic triple-negative breast cancer (mTNBC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1011-1011
Author(s):  
Kevin Kalinsky ◽  
Mafalda Oliveira ◽  
Tiffany A. Traina ◽  
Sara M. Tolaney ◽  
Delphine Loirat ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Single Agent ◽  
Progression Free Survival ◽  
Antibody Drug Conjugate ◽  
Phase 3 ◽  
Best Response ◽  
Significant Survival ◽  
Independent Review ◽  
Grade 3 ◽  
The Impact

1011 Background: Approximately 20% of pts diagnosed with TNBC are aged ≥65 y. Often, older pts are less fit for chemotherapy due to a greater rate of comorbidities, increased use of medications, and pre-existing frailty or functional loss. SG is an antibody-drug conjugate composed of an anti–Trop-2 antibody coupled to the cytotoxic SN-38 payload via a proprietary, hydrolyzable linker. The landmark phase 3 ASCENT study (NCT02574455) showed improved outcomes with SG vs single-agent chemotherapy of physician’s choice (TPC) in pts with relapsed/refractory mTNBC (median progression-free survival [PFS], 5.6 vs 1.7 mo; median overall survival [OS], 12.1 vs 6.7 mo). Here we assess the impact of age on the efficacy and safety of SG in ASCENT. Methods: Pts with mTNBC refractory/relapsing after ≥2 prior chemotherapies were randomized 1:1 to receive SG (10 mg/kg IV on days 1 and 8, every 21 days) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression/unacceptable toxicity. Primary endpoint was PFS per RECIST 1.1 by independent review in brain metastases-negative (BMNeg) pts. Safety outcomes were assessed in all treated pts. This prespecified subgroup analysis assessed the impact of age (pts ≥65 y) on PFS, OS, and safety. Results: Of 529 pts enrolled, 468 were BMNeg (median age, 54 y); of these, 44/235 pts (19%) who received SG and 46/233 pts (20%) who received TPC were aged ≥65 y. SG treatment improved median PFS vs TPC in pts ≥65 y (7.1 vs 2.4 mo; HR, 0.22; 95% CI, 0.12-0.40). SG vs TPC treatment also improved median OS in pts ≥65 y (15.3 vs 8.2 mo; HR, 0.37; 95% CI, 0.22-0.64). Treatment with SG vs TPC resulted in higher ORR (50% vs 0%) and clinical benefit rate (CBR, 61% vs 9%) in pts ≥65 y. Of the 7 pts ≥75 y who received SG, 2 had partial response, 4 had stable disease [SD], and 1 had SD > 6 mo as best response. In pts < 65 y, median PFS for SG vs TPC was 4.6 vs 1.7 mo (HR, 0.46; 95% CI, 0.35-0.59), and median OS was 11.2 vs 6.6 mo (HR, 0.50; 95% CI, 0.40-0.64), respectively; the ORR and CBR were 31% vs 6% and 41% vs 9%, respectively. Pts ≥65 y treated with SG vs TPC had similar rates of all grade and grade ≥3 treatment-emergent adverse events (TEAEs). TEAEs leading to dose reduction were similar in pts ≥65 y in the SG vs TPC arms (35% vs 33%) and were lower in pts < 65 y (19% vs 24%). Key treatment-related TEAEs leading to dose reduction in pts ≥65 y in the SG vs TPC arms were neutropenia (including febrile neutropenia; 14% vs 25%), fatigue (10% vs 4%), diarrhea (6% vs 0%), and nausea (4% vs 0%). TEAEs leading to treatment discontinuation with SG vs TPC were low in pts ≥65 y (2% vs 2%) and < 65 y (5% vs 6%). There were no treatment-related AEs leading to death in any SG-treated age group. Conclusions: Irrespective of age, pts who received SG had a significant survival benefit vs TPC, with a tolerable safety profile. Proactive AE monitoring and management will allow optimal therapeutic exposure to SG in older pts. Clinical trial information: NCT02574455 .

Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma

Blood ◽  
2009 ◽  
Vol 114 (4) ◽  
pp. 772-778 ◽  
Author(s):  
Paul Richardson ◽  
Sundar Jagannath ◽  
Mohamad Hussein ◽  
James Berenson ◽  
Seema Singhal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Single Agent ◽  
Progression Free Survival ◽  
Prior Treatment ◽  
Once Daily ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Treatment Regimens ◽  
Common Grade ◽  
Grade 3

Abstract Lenalidomide plus dexamethasone is effective for the treatment of relapsed and refractory multiple myeloma (MM); however, toxicities from dexamethasone can be dose limiting. We evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed and refractory MM. Patients (N = 222) received lenalidomide 30 mg/day once daily (days 1-21 every 28 days) until disease progression or intolerance. Response, progression-free survival (PFS), overall survival (OS), time to progression (TTP), and safety were assessed. Overall, 67% of patients had received 3 or more prior treatment regimens. Partial response or better was reported in 26% of patients, with minimal response 18%. There was no difference between patients who had received 2 or fewer versus 3 or more prior treatment regimens (45% vs 44%, respectively). Median values for TTP, PFS, and OS were 5.2, 4.9, and 23.2 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (60%), thrombocytopenia (39%), and anemia (20%), which proved manageable with dose reduction. Grade 3 or 4 febrile neutropenia occurred in 4% of patients. Lenalidomide monotherapy is active in relapsed and refractory MM with acceptable toxicities. These data support treatment with single-agent lenalidomide, as well as its use in steroid-sparing combination approaches. The study is registered at http://www.clinicaltrials.gov as NCT00065351.

scholarly journals Phase II Trial of Cetuximab With or Without Paclitaxel in Patients With Advanced Urothelial Tract Carcinoma

2012 ◽  
Vol 30 (28) ◽  
pp. 3545-3551 ◽  
Author(s):  
Yu-Ning Wong ◽  
Samuel Litwin ◽  
David Vaughn ◽  
Seth Cohen ◽  
Elizabeth R. Plimack ◽  
...  
Keyword(s):  
Phase Ii ◽  
Urothelial Cancer ◽  
Single Agent ◽  
Progression Free Survival ◽  
Salvage Chemotherapy ◽  
Free Survival ◽  
Metastatic Urothelial Cancer ◽  
Metastatic Setting ◽  
Previously Treated ◽  
Grade 3

Purpose The benefit of salvage chemotherapy is modest in metastatic urothelial cancer. We conducted a randomized, noncomparative phase II study to measure the efficacy of cetuximab with or without paclitaxel in patients with previously treated urothelial cancer. Patients and Methods Patients with metastatic urothelial cancer who received one line of chemotherapy in the perioperative or metastatic setting were randomly assigned to 4-week cycles of cetuximab 250 mg/m2 with or without paclitaxel 80 mg/m2 per week. We used early progression as an indicator of futility. Either arm would close if seven of the initial 15 patients in that arm progressed at the first disease evaluation at 8 weeks. Results We enrolled 39 evaluable patients. The single-agent cetuximab arm closed after nine of the first 11 patients progressed by 8 weeks. The combination arm completed the full accrual of 28 patients, of whom 22 patients (78.5%) had visceral disease. Twelve of 28 patients had progression-free survival greater than 16 weeks. The overall response rate was 25% (95% CI, 11% to 45%; three complete responses and four partial responses). The median progression-free survival was 16.4 weeks (95% CI, 12 to 25.1 weeks), and the median overall survival was 42 weeks (95% CI, 30.4 to 78 weeks). Treatment-related grade 3 and 4 adverse events that occurred in at least two patients were rash (six cases), fatigue (five cases), and low magnesium (three cases). Conclusion Although it had limited activity as a single agent, cetuximab appears to augment the antitumor activity of paclitaxel in previously treated urothelial cancers. The cetuximab and paclitaxel combination merits additional study to establish its role in the treatment of urothelial cancers.

GEIS 39: Phase II trial of nabpaclitaxel for the treatment of patient with multiply relapsed/refractory desmoplastic small round cell tumor (DSRCT) and Ewing sarcoma (EwS).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11529-11529
Author(s):  
Jaume Mora ◽  
Mariona Suñol ◽  
Nadia Hindi ◽  
Alicia Castañeda ◽  
Andrés Redondo ◽  
...  
Keyword(s):  
Single Agent ◽  
Progression Free Survival ◽  
Predictive Biomarker ◽  
Free Survival ◽  
Pediatric Solid Tumors ◽  
Meaningful Activity ◽  
Common Grade ◽  
Central Pathology ◽  
Grade 3 ◽  
Further Development

11529 Background: Nab-paclitaxel (albumin-bound paclitaxel) has shown preclinical activity against pediatric solid tumors. Preclinical data in EwS PDX models suggested high activity of nab-paclitaxel in tumors expressing high-levels of SPARC. Tumoral SPARC facilitates the accumulation of albumin in the tumor and increases the effectiveness of albumin-bound paclitaxel. Nab-paclitaxel utilizes albumin to deliver paclitaxel via caveolin-mediated endocytosis which is expressed in the EwS cells surface. We hypothesized that SPARC can be a predictive biomarker for nab-paclitaxel in EwS and DSRCT that could potentially be relevant for a better design of clinical trials and personalized treatments using nab-paclitaxel. Methods: Main endpoint of GEIS-39 was the overall response rate (ORR) assessed by RECIST 1.1 criteria with centralized pathology and imaging review. Secondary objectives included safety according to the CTCAE 4.0 criteria. Patients aged ≥ 6 months and ≤ 40 years, with relapsed/refractory DSRCT were eligible after having received at least one previous poly-chemotherapy line; EwS must have received at least two standard chemotherapy lines. Prior taxane therapy was accepted. Central pathology review selected for tumors with > Grade 3 (intense and diffuse) expression of SPARC by immunohistochemistry to be eligible. Nab-paclitaxel was administered as follows: age ≥ 21 and ≤ 40 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days; age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days. A 30% ORR was anticipated with a sample size of 25 patients needed to test the hypothesis. Stopping rule was set at 1 response within the first 16 treated pts. If 5 or more successes were observed in 25 pts, the results of the trial will warrant further investigation. Results: Twenty-nine patients were enrolled from June 2017 until October 2019, 11 DSRCT and 18 EwS. Median age was 32 years (range 14-69), and 5 females and 24 males were included, having received a median of 3 previous systemic treatment lines. Patients received a median of 3 cycles of nab-paclitaxel (range 1-17). In the EwS cohort an ORR of 33.3% (all partial responses, median duration 2 months) and 16.7% of stabilizations were achieved. No objective responses were observed among DSRCT pts, but 27.3% of pts achieved a stabilization. Overall, median progression free survival was 2.8 months and median overall survival 12.1 months, with no significant differences between DSRCT and EwS cohorts. Most common grade 3 toxicities were neutropenia (20.7%) and diarrhea (10.3%). Conclusions: Single agent nab-paclitaxel in biomarker selected EwS patients, but not in DSRCT, provided clinically meaningful activity that deserves further development. Nab-paclitaxel had a manageable adverse event profile. Clinical trial information: 2016-002464-14.

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