Comparison of efficacy and safety of first-line palliative chemotherapy with TX and XELOX regimens in patients with metastatic gastric adenocarcinoma: A randomized phase II trial.

4070 Background: Docetaxel has shown antitumor activity in the treatment of MGC as a single or combination chemotherapy. This study was designed to compare the clinical outcome of docetaxel based and platinum based doublet regimen as first-line treatment in MGC patients. Methods: In an open, randomized, single center phase II trial, 134 pts were randomly assigned and treated with either TX (capecitabine 1g/m2/twice daily/ 1-14 days and docetaxel 75mg/m2 in 1st day) or XELOX (capecitabine 1g/m2/twice daily/ 1-14 days and oxaliplatin 130 mg/m2 in 1st day) as first-line chemotherapy. The primary endpoint is finding potential predictive factors, secondary endpoint is ORR, PFS, OS and safety. After progression, patients were switched into the other group. Results: Now, the potential predictive factors are testing in genomics and proteomics. In 134 randomly assigned and treated pts (TX = 69; XELOX = 65). Most pts were male (87pts).Overall survival was longer with TX versus XELOX (13.1m vs. 9.6m, p = 0.173), but no statistical differences. Progression free survival was similar with TX versus XELOX (4.57m vs. 5.27m, p = 0.297). Overall response rate was equal with TX versus XELOX (50.8% vs. 47.6%, p = 0.72). G3-4 treatment-related AE occurred in 60.6% (TX) v 55.4% (XELOX) of patients. Frequent G3-4 toxicities for TX v XELOX were: neutropenia (60.6% v 15.4%), febrile granulocyte deficiency (17.4% v 1.5%), anemia (10.1% v 10.8%), thrombocytopenia (1.4% v 15.4%), and all grade peripheral neurotoxicity (11.6% v 38.5%).After first-line treatment failure, 35 patients in the TX group switched to XELOX, and 27 patients in the XELOX group switched to TX, and there is also no significant difference in survival time from the first-line treatment between the two groups (p = 0.129). Conclusions: Although TX led to more neutropenia, first-line palliative chemotherapy with docetaxel based doublet regimens provides a new choice and can gain almost the same response rate and survival time as frequently-used fluorouracil and platinum based regimen. And potential predictive factors will indicate who will get more benefit from taxanes or platinums. Clinical trial information: NCT01963702.

Download Full-text

The impact of cetuximab on the capecitabine plus oxaliplatin (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.3551 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 3551-3551 ◽

Cited By ~ 10

Author(s):

M. Borner ◽

W. Mingrone ◽

D. Koeberle ◽

R. Von Moos ◽

D. Rauch ◽

...

Keyword(s):

Phase Ii ◽

Response Rate ◽

Phase Ii Trial ◽

High Response ◽

Line Treatment ◽

First Line ◽

Clinical Cancer Research ◽

Grade 3 ◽

The Impact ◽

First Line Treatment

3551 Background: XELOX is a valuable alternative to continuous infusion FOLFOX type regimens in the treatment of MCC (Borner et al, JCO 2002, 1759). Cetuximab is an EGFR antibody, which has been shown to improve the efficacy of chemotherapy. A phase II study in first-line treatment of MCC has demonstrated a high response rate combining cetuximab with FOLFOX (Tabernero et al, Proc ASCO 2004, 3512). Methods: Multicenter, randomized two-arm phase II trial: OXA 130 mg/m2 day 1 and oral CAP 1000 mg/m2 bid days 1–14 every 21 days alone or in combination with cetuximab 250 mg/m2 weekly after a loading dose of 400 mg/m2. Treatment was limited to a maximum of 6 cycles. With 37 patients in each arm, the power was 90% to select the truly better arm if the true between-arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until October 2005. Results: We present here the results of 74 patients included in the study. In 67 patients the first response data are available (investigators’ assessment after 3 cycles). The two arms are well balanced for relevant patient, disease and treatment characteristics. The study treatment was well tolerated with grade 3/4 toxicities in < 10% of the cycles in each arm. The frequency of side effects was balanced, but with more frequent skin toxicity in the cetuximab arm (6% versus 0% grade 3/4). Conclusions: Cetuximab seems to positively interact with XELOX in terms of efficacy but not toxicity. The cetuximab/XELOX combination appears to be a valuable option in first-line treatment of MCC especially if high response rates are a primary objective. This trial was supported in part by Merck KGaA and Sanofi-Aventis Switzerland. [Table: see text] No significant financial relationships to disclose.

Download Full-text

First-line treatment with single agent rituximab, followed by maintenance rituximab plus anti-idiotype Id-KLH active immunotherapy vaccine (FavId) in patients (pts) with low-grade non-Hodgkin lymphoma (NHL): Preliminary results of a phase II trial

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.8080 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 8080-8080 ◽

Cited By ~ 1

Author(s):

E. Raefsky ◽

F. A. Greco ◽

D. R. Spigel ◽

S. Litchy ◽

V. Gian ◽

...

Keyword(s):

Maintenance Therapy ◽

Phase Ii ◽

Response Rate ◽

Phase Ii Trial ◽

Single Agent ◽

Active Immunotherapy ◽

Low Grade ◽

Line Treatment ◽

First Line ◽

First Line Treatment

8080 Background: Single agent rituximab produces a high response rate when used as first-line treatment, and maintenance rituximab prolongs remission duration. Active immunotherapy is a promising treatment approach, when administered following remission induction by initial therapy. In this phase II trial, we evaluate the feasibility, toxicity, and efficacy of administering concurrent maintenance rituximab plus Id-KLH vaccine in pts with low-grade NHL. Methods: Pts with previously untreated low-grade NHL (grade 1/2 follicular or SLL) who were judged to be candidates for single agent rituximab therapy were eligible. All pts had initial biopsy for production of the Id-KLH vaccine. All pts received rituximab 375mg/m2 IV, weekly × 4. Pts with CR/CRu, PR, or stable disease at 8 weeks proceeded with maintenance rituximab (standard 4 week courses at 6 month intervals for 3 courses) and Id-KLH vaccination (Id-KLH 1cc day 1; GMCSF 250μg SQ days 1–4) monthly × 8, beginning month 3, then every 2 months during the second year. Pts were monitored for response rate, progression- free survival, and toxicity. Results: To date, 36 of a planned 56 pts have been enrolled. Idiotype vaccine was successfully manufactured in 27 of 32 pts (84%), with 4 in production. Of the 27 pts for whom Id-KLH was successfully manufactured, 2 progressed during rituximab. 19 of 25 pts (14FL;5SLL) have had response determined after rituximab: 8 PR (42%), 11 stable (58%; 4 of 5 SLL). Pts have now received rituximab maintenance therapy plus Id-KLH for durations of 6 - 34 months. 6 of 19 pts (3 SLL) progressed at months 5, 6, 9, 9, 10, and 12, respectively. Treatment has been well tolerated, with no unusual toxicities observed. Rituximab-related hypotension and atrial fibrillation occurred in 1 pt. The most common Id-KLH related adverse event has been injection site reaction. Conclusions: Concurrent maintenance therapy with rituximab plus Id-KLH is safe and well tolerated. At present, 6 of 25 pts (24%) have progressed (including 3 of the 5 SLL pts) with a median followup of 19 months. This trial is continuing. No significant financial relationships to disclose.

Download Full-text