(Pleural Mesothelioma) Cediranib Plus Pemetrexed Disodium Plus Cisplatin: Is It Effective?
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هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
- September 17, 2019
- 2 min read
On August 6, 2019, Dr. Anne S. Tsao published results in the Journal of Clinical Oncology from the SWOG S0905 Phase 2 clinical trial evaluating the efficacy and safety of combining the anti-VEGFR inhibitor Cediranib with pemetrexed disodium and cisplatin in unresectable, chemotherapy-naive malignant pleural mesothelioma patients.
The SWOG S0905 trial was a randomized Phase 2 study enrolling 92 patients with unresectable, chemotherapy-naive malignant pleural mesothelioma. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS) and objective response rate (ORR). Treatment was on a 21-day cycle:
- Cediranib group (N=45): Pemetrexed 500 mg/m² (Day 1) + Cisplatin 75 mg/m² (Day 1) + Cediranib 20 mg orally once daily (Days 1–21)
- Placebo group (N=47): Pemetrexed 500 mg/m² (Day 1) + Cisplatin 75 mg/m² (Day 1) + Placebo once daily (Days 1–21)
Background: Malignant pleural mesothelioma is a rare cancer with poor prognosis and limited treatment options. Systemic chemotherapy combined with VEGFR inhibitors was expected to enhance anti-tumor efficacy. This trial evaluated oral VEGFR inhibitor Cediranib combined with chemotherapy.
Patient Demographics:
| Parameter | Cediranib | Placebo |
|---|---|---|
| Median age | 72 years (46–82) | 72 years (51–85) |
| Male | 84% | 85% |
| Caucasian | 96% | 89% |
| ECOG 0–1 | 93% | 94% |
| Prior radiation | 18% | 19% |
| Prior neo/adjuvant chemo | 13% | 13% |
Results at median follow-up of 31 months:
Primary endpoint median PFS: Cediranib 7.2 months vs. placebo 5.6 months — Cediranib improved disease progression risk by 29% (HR: 0.71).
Secondary endpoint median OS: Cediranib 10 months vs. placebo 8.5 months — Cediranib improved survival risk by 12%, but without statistical significance (HR: 0.88). ORR: Cediranib 50% vs. placebo 20% — statistically significant improvement.
Safety:
Overall adverse event incidence: Cediranib 100% vs. placebo 91%. Grade 3–4 adverse events: Cediranib 69% vs. placebo 57%. Higher rates in the Cediranib arm included: anorexia (51% vs. 38%), diarrhea (46.7% vs. 17%), epistaxis (13% vs. 0%), muscle atrophy (16% vs. 9%), hypertension (44% vs. 15%), nausea (76% vs. 66%), peripheral neuropathy (20% vs. 11%), weight loss (36% vs. 21%), myelosuppression (44% vs. 30%).
Conclusion: Based on the SWOG S0905 trial results, Dr. Tsao concluded that Cediranib combined with pemetrexed disodium and cisplatin improved PFS and ORR in unresectable, chemotherapy-naive malignant pleural mesothelioma patients.
Disclaimer: Medical Supporter translates overseas clinical trial data for informational purposes only. Please consult your healthcare provider for medical decisions.
Source: Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905). J Clin Oncol. 2019 Aug 6: JCO1900269.
Pleural Mesothelioma
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