Capecitabine/ irinotecan (CapIri) and capecitabine/oxaliplatin (CapOx) are active second-line protocols in patients with advanced colorectal cancer (ACRC) after failure of first-line combination therapy: Results of a randomized phase II study
2004; Lippincott Williams & Wilkins; Volume: 22; Issue: 14_suppl Linguagem: Inglês
10.1200/jco.2004.22.90140.3534
ISSN1527-7755
AutoresAxel Grothey, Kim Jordan, O Kellner, Carolina Constantin, Georg Dietrich, Hendrik Kroening, LG Mantovani, C. Schlichting, Helmut Forstbauer, Hans‐Joachim Schmoll,
Tópico(s)Gastric Cancer Management and Outcomes
Resumo3534 Background: Previously, we reported the interim results of a randomized phase II trial with CapIri vs CapOx as first-line therapy in ACRC (Grothey et al., ASCO 2003). The study protocol included a recommended cross-over as second-line therapy. Here we present the results of CapIri and CapOx as second-line treatment in patients with ACRC, pretreated with a capecitabine-based combination regimen. Methods: Treatment protocols consisted of capecitabine 1000 mg/m2 bid d1–14 plus irinotecan 100 mg/m2 iv d1,8 or oxaliplatin 70 mg/m2 iv d1,8; qd 22. A total of 161 patients (pts) were initially randomized in the phase II trial, of which 68 received CapOx or CapIri as 2nd-line therapy within the protocol (33 pts CapOx after CapIri, 35 pts CapIri after CapOx). Results: NCI-CTC grade 3/4 toxicities for 2nd-line therapies (CapIri vs CapOx): anemia 2.7% vs 6.0%, thrombocytopenia 8.1% vs 3.0%, diarrhea 10.8% vs 0%, nausea/vomiting 0% vs 3.0%, infection 2.7% vs 3.0%, bilirubin 8.6% vs 6.4%; HFS grade 2/3 13.5% vs 3.0%, alopecia grade 2 21.6% vs 9.1%. Grade 3 sensory neurotoxicity was present in 10.8% of pts at onset of 2nd line CapIri, but decreased by at least one grade in all pts after 3 cycles CapIri. Efficacy (CapIri vs CapOx): RR 20.6% vs 12.7%, SD 50% vs 48.4%, PD 29.4% vs 38.7%; PFS 5.1 mos vs 4.3 mos; OS (after start of 2nd-line) 9.6 mos vs 10.6 mos. Overall survivals for pts with 1st- and 2nd-line sequential therapy were almost identical: CapOx->CapIri 17.8 mos, CapIri->CapOx 17.7 mos. Conclusions: CapIri and CapOx are both effective and tolerable second-line treatment regimens after capecitabine-based first-line combination therapy. Severe diarrhea was more frequently associated with second-line CapIri, oxaliplatin-mediated sensory neurotoxicity after first-line CapOx was reversible under second-line CapIri. Overall efficacy parameters of our randomized phase II trial do not suggest superiority of a particular treatment sequence. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthelabo Sanofi-Synthelabo Sanofi-Synthelabo; Hoffmann-LaRoche; Aventis
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