First-line simplified GEMOX (D1-D1) versus classical GEMOX (D1-D2) in metastatic pancreatic adenocarcinoma (MPA). A GERCOR randomized phase II study
| Autor: | Pascal Artru, Gérard Lledo, C. Louvet, L. Mineur, Paitel Jf, A. de Gramont, Pauline Afchain, S. Nguyen, Frédéric Selle, T. Andre |
|---|---|
| Rok vydání: | 2007 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 25:4592-4592 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2007.25.18_suppl.4592 |
| Popis: | 4592 Background: GEMOX was defined as a D1-D2 schedule, based on preclinical data. In order to improve convenience for patients, we evaluated a simplified D1-D1GEMOX regimen (S-GEMOX) in MPA. Methods: Patients (pts) with MPA were 2:1 randomly assigned for first-line treatment to S-GEMOX (arm A : gemcitabine 1,000mg/m2, 100 min infusion D1 immediately followed by oxaliplatin 100 mg/m2, 120 min infusion) or to GEMOX (arm B : gem D1 and ox D2). Treatment was repeated in each arm every 2 weeks until disease progression. Stratification was performed on centre and PS. Results: Fifty-seven pts were enrolled, A = 37 (PS 2 : 22%), B = 20 (PS 2 : 20%). Populations were well balanced for age (64.9 yrs vs 66.6), gender (57% male vs 65), location of primary tumor (pancreas head 49% vs 50), and metastasic sites (liver 76% vs 85; peritoneum 24% vs 20; lung 16% vs 10; lymph nodes 14% vs 15; other 5% vs 5). Tumor differentiation significantly differed among the 2 groups (A : 8% poorly differentiated vs B : 36%). Response rate was 27% (95% CI : 12–42) in arm A and 10% (95% CI : 0 - 23) in arm B. Median PFS was 4.0 and 2.5 months in arm A and B, respectively. Median OS was 7.6 and 3.2 months in arm A and B, respectively. S-GEMOX was more toxic than GEMOX for gr 3–4 neutropenia (20% vs 0%) and thrombocytopenia (16% vs 10%). Other toxicities were comparable. However, since more cycles were administered in arm A (8.5 (1–29) vs 5.8 (2–12)), gr 3 oxaliplatin- induced neuropathy was higher in arm A (21.6% vs 0%). Conclusions: S-GEMOX is active in MPA. This activity is in the same range as compared to our previous experiences of GEMOX. The very bad outcome of pts randomized in arm B could be in part explained by the high rate of poorly differentiated tumors. This study emphazises one more time the limit of studies with small sample size of pts in MPA. No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|