Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4069
© 2007 American Society of Clinical Oncology

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Abstract

Randomized strategical trial of chemotherapy in metastatic colorectal cancer (FFCD 2000–05): Preliminary results

Hôpital Robert Debré, Reims, France; Institut Gustave-Roussy, Villejuif, France; Clinique Armoricaine, Saint Brieuc, France; Centre Hospitalier, Mont de Marsan, France; Centre Hospitalier, Libourne, France; Centre Hospitalier Universitaire, Dijon, France; Hôpital Ambroise- Paré, Boulogne-Billancourt, France; Centre Hospitalier, Blois, France; Hôpital Nord, Marseille, France

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Background: The survival benefit of using a combination therapy instead of keeping it for a second line (L2) has not been demonstrated in metastatic colorectal cancer. The purpose of this trial was to compare the efficacy of simplified LV5FU2 (s) followed by FOLFOX6 (arm A) to FOLFOX6 followed by FOLFIRI (arm B) on progression-free survival after two lines of chemotherapy. We present here preliminary results relating to toxicity, observance and overall survival. Methods: Inclusion criteria: a) non resectable metastases of histologically proven colorectal adenocarcinoma , b) evaluable disease (WHO criteria), c) absence of previous chemotherapy other than adjuvant. Treatment was as follows: LV5FU2s = at day 1, folinic acid 400 mg/m², 5-FU bolus 400 mg/m² and continuous infusion over 46 hours 2,400 mg/m²/2 weeks; FOLFOX6 = LV5FU2s + oxaliplatin 100 mg/m² at day 1; FOLFIRI = LV5FU2s + irinotecan 180 mg/m² at day 1. Results: 410 pts out of 570 initially planned (early stopping due to slow accrual and new treatments) were included from 02/2002 to 02/2006 (205 in each arm). Median follow-up was 25 months. The median number (range) of cycles (28 days) in first line (L1) was respectively 5 (1–24) and 6 (1–24) in the arms A and B (p=0.01), and for L2 (152 and 144 pts in the arms A/B): 5 (1–17) and 3 (1–33) (NS). In the arms A and B, 74% and 70% of pts had L2. L1 was stopped for toxicity for 1% and 16% of the pts in arms A and B (p<0.0001); L2 respectively for 15% and 2% pts (p<0.0001). The percentages of pts presenting at least a grade 3–4 hematologic toxicity (mainly neutropenia) by arm were: 6% versus 37% (p<0.0001) for L1 and 30% versus 27% (NS) for L2; grade 3–4 non hematological toxicity (grade 2–4 neurotoxicity): 26% (1%) versus 56% (64%)(p<0.0001; p<0.0001) for L1 and 54% (60%) versus 46% (40%) of the pts for L2 (NS; p<0.01). No toxic death was observed in the arm A against 5 in the arm B: 3 in L1 and 2 in L2. Overall survival medians were 17 and 16 months in arms A/B (logrank p=0.64) (preliminary results, 291 observed deaths). Conclusions: This trial does not show any substantial difference in treatment duration and overall survival between both arms and shows a more important toxicity in the arm with first line combined chemotherapy.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting