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FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced
* w w w .ncbi.nlm.nih.gov/pubmed/14657227
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced
colorectal cancer: a randomized GERCOR study.
Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D,
Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de
Gramont A.
Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75571 Paris,
Cedex 12, France. aimery.de-gramont@sat.ap-hop-paris . fr
PURPOSE: In metastatic colorectal cancer, phase III studies have
demonstrated the superiority of fluorouracil (FU) with leucovorin (LV) in
combination with irinotecan or oxaliplatin over FU + LV alone. This phase
III study investigated two sequences: folinic acid, FU, and irinotecan
(FOLFIRI) followed by folinic acid, FU, and oxaliplatin (FOLFOX6; arm A),
and FOLFOX6 followed by FOLFIRI (arm B).
PATIENTS AND METHODS: Previously untreated patients with assessable
disease were randomly assigned to receive a 2-hour infusion of l-LV 200
mg/m(2) or dl-LV 400 mg/m(2) followed by a FU bolus 400 mg/m(2) and
46-hour infusion 2,400 to 3,000 mg/m(2) every 46 hours every 2 weeks,
either with irinotecan 180 mg/m(2) or with oxaliplatin 100 mg/m(2) as a
2-hour infusion on day 1. At progression, irinotecan was replaced by
oxaliplatin (arm A), or oxaliplatin by irinotecan (arm B).
RESULT: Median survival was 21.5 months in 109 patients allocated to
FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to
FOLFOX6 then FOLFIRI (P =.99).
Median second progression-free survival (PFS) was 14.2 months in arm A
versus 10.9 in arm B (P =.64).
In first-line therapy, FOLFIRI achieved 56% response rate (RR) and 8.5
months median PFS, versus FOLFOX6 which achieved 54% RR and 8.0 months
median PFS (P =.26).
Second-line FOLFIRI achieved 4% RR and 2.5 months median PFS, versus
FOLFOX6 which achieved 15% RR and 4.2 months PFS.
In first-line therapy, National Cancer Institute Common Toxicity Criteria
grade 3/4 mucositis, nausea/vomiting, and grade 2 alopecia were more
frequent with FOLFIRI, and grade 3/4 neutropenia and neurosensory toxicity
were more frequent with FOLFOX6.
CONCLUSION: Both sequences achieved a prolonged survival and similar
efficacy. The toxicity profiles were different.
PMID: 14657227 [PubMed - indexed for MEDLINE]
* w w w .ncbi.nlm.nih.gov/pubmed/14657227
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced
colorectal cancer: a randomized GERCOR study.
Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D,
Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de
Gramont A.
Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75571 Paris,
Cedex 12, France. aimery.de-gramont@sat.ap-hop-paris . fr
PURPOSE: In metastatic colorectal cancer, phase III studies have
demonstrated the superiority of fluorouracil (FU) with leucovorin (LV) in
combination with irinotecan or oxaliplatin over FU + LV alone. This phase
III study investigated two sequences: folinic acid, FU, and irinotecan
(FOLFIRI) followed by folinic acid, FU, and oxaliplatin (FOLFOX6; arm A),
and FOLFOX6 followed by FOLFIRI (arm B).
PATIENTS AND METHODS: Previously untreated patients with assessable
disease were randomly assigned to receive a 2-hour infusion of l-LV 200
mg/m(2) or dl-LV 400 mg/m(2) followed by a FU bolus 400 mg/m(2) and
46-hour infusion 2,400 to 3,000 mg/m(2) every 46 hours every 2 weeks,
either with irinotecan 180 mg/m(2) or with oxaliplatin 100 mg/m(2) as a
2-hour infusion on day 1. At progression, irinotecan was replaced by
oxaliplatin (arm A), or oxaliplatin by irinotecan (arm B).
RESULT: Median survival was 21.5 months in 109 patients allocated to
FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to
FOLFOX6 then FOLFIRI (P =.99).
Median second progression-free survival (PFS) was 14.2 months in arm A
versus 10.9 in arm B (P =.64).
In first-line therapy, FOLFIRI achieved 56% response rate (RR) and 8.5
months median PFS, versus FOLFOX6 which achieved 54% RR and 8.0 months
median PFS (P =.26).
Second-line FOLFIRI achieved 4% RR and 2.5 months median PFS, versus
FOLFOX6 which achieved 15% RR and 4.2 months PFS.
In first-line therapy, National Cancer Institute Common Toxicity Criteria
grade 3/4 mucositis, nausea/vomiting, and grade 2 alopecia were more
frequent with FOLFIRI, and grade 3/4 neutropenia and neurosensory toxicity
were more frequent with FOLFOX6.
CONCLUSION: Both sequences achieved a prolonged survival and similar
efficacy. The toxicity profiles were different.
PMID: 14657227 [PubMed - indexed for MEDLINE]
