Phase II trial of irinotecan, carboplatin, and bevacizumab in patients with limited-stage small cell lung cancer
| Autor: | John D. Hainsworth, E. Vazquez, C. Farley, John D. Zubkus, J. F. Patton, Lowell L. Hart, David R. Spigel, F. A. Greco, D. A. Yardley, H. A. Burris |
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| Rok vydání: | 2007 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Bevacizumab business.industry medicine.medical_treatment Carboplatin Surgery Irinotecan Radiation therapy chemistry.chemical_compound Maintenance therapy chemistry Internal medicine medicine In patient business Extensive-stage small cell lung cancer medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 25:18133-18133 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 18133 Background: In a previously reported phase II trial bevacizumab (B) was used as maintenance therapy following induction with irinotecan (I), carboplatin (C) and radiotherapy (RT) in patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). 1-year progression- free survival (PFS) and overall survival (OS) were 53% and 70%, respectively. In the present multicenter community-based trial B is given with induction chemoradiotherapy and as maintenance therapy. Methods: The primary endpoint is to assess the median PFS. Eligibility criteria: newly diagnosed LS-SCLC, measurable disease, ECOG PS 0–1, and informed consent. Exclusion criteria: hemoptysis and therapeutic anticoagulation. Treatment: I 60mg/m2 IV D1, 8, 15, C AUC=4 IV D1, and B 10 mg/kg IV D1 and 15 every 28D. Pts received concurrent RT to 61.2 Gy starting with the 3rd cycle, and were restaged every 8 weeks. If no progressive disease (PD) or excessive toxicity after 4 cycles, pts received B x 6 months. Prophylactic cranial irradiation was used at M.D. discretion. This 2-stage trial was designed to achieve a 40% improvement in historical median PFS of 12–14 months. Results: 20 pts were enrolled from 4/06 to 12/06 (trial ongoing, n=50 planned). Data are available for 14 pts in this analysis. Baseline features: median age 64 years; male/female, 21%/79%; and ECOG PS 0/1, 64%/36%. The objective response rate was 78% (95% CI 45%-94%) - all partial responses. No pt had PD. 7 pts were not evaluable: too early, 5 pts; off study (toxic megacolon, 1 pt; intercurrent illness, 1 pt). With a median follow-up of 5 months, the median PFS has not been reached. Grade (G) 3/4 non-hematologic toxicity with induction occurring in more than 2 pts: diarrhea (29%) and esophagitis, fatigue, pain (21% each). G3/4 hematologic toxicity: leukopenia (21%), neutropenia (14%), and thrombocytopenia (43%). There have been 2 G3/4 bleeding events with induction: suspected tracheoesophageal fistula with death (possibly treatment-related), 1 pt; and hematochezia, unrelated, 1 pt. Conclusions: This trial continues to be closely monitored for safety. Further accrual and longer follow-up are necessary to assess if B can be safely combined with chemoradiotherapy and improve efficacy. No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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