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Pemetrexed in second line and beyond small cell lung cancer: a Hoosier Oncology Group phase II study
Shadia Jalal1, Rafat Ansari, Ramaswamy Govindan
1Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indianapolis, USA. sjalal@iupui.edu
Introduction:
: Small cell lung cancer (SCLC) is initially a chemotherapy-sensitive disease. Nevertheless, drug-resistance results in disease recurrence in most patients. Many drugs, including antimetabolites, are active, but only minimal progress has been made in improving survival times for those with advanced disease. Based on the need to discover better systemic therapies, we conducted a phase II study of pemetrexed in patients with relapsed SCLC.
Patients And Methods:
: Eligible patients had SCLC or poorly differentiated neuroendocrine cancers of the lung, Eastern Cooperative Oncology Group performance status of 0 to 2, and had received less than or equal to two prior chemotherapy regimens (additional targeted agents were allowed). Both chemotherapy-sensitive (relapse >/=90 days from completion of first line therapy) and chemotherapy-resistant (progressive disease during or within 90 days from completion of first line treatment) patients were eligible and analyzed separately. Pemetrexed was administered at 500 mg/m intravenously every 21 days for up to six cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. The primary objective of the trial was to estimate the clinical benefit rate (complete plus partial response plus stable disease) in each group.
Results:
: From January 2005 to September 2005, 20 patients were enrolled in the chemotherapy-sensitive arm and 23 patients in the chemotherapy-resistant arm. The majority of patients were men, the median age of the two groups were 62.5 and 65, respectively; 75% had a performance status of 0 or 1, and more than 50% had received more than one prior regimen. Grade 3/4 toxicities were as expected for pemetrexed. Progressive disease was the best response in 16 patients (80%) in the chemo-sensitive group and 19 patients (83%) in the chemo-refractory group. One patient had a partial response and three had stable disease in each group.
Conclusion:
: Pemetrexed has minimal single agent activity in relapsed SCLC.
Insights
Pemetrexed showed minimal effectiveness as a single treatment for patients with relapsed small cell lung cancer (SCLC). Further research is needed for better systemic therapies in advanced SCLC.
Area of Science:
- Oncology
- Medical Oncology
- Pulmonology
Background:
- Small cell lung cancer (SCLC) is initially responsive to chemotherapy but often recurs due to drug resistance.
- Limited progress has been made in improving survival for advanced SCLC patients.
- There is a critical need for novel systemic therapies for relapsed SCLC.
Purpose of the Study:
- To evaluate the efficacy of pemetrexed as a single agent in patients with relapsed SCLC.
- To assess the clinical benefit rate in both chemotherapy-sensitive and chemotherapy-resistant SCLC patient groups.
Main Methods:
- A phase II study was conducted involving patients with relapsed SCLC or poorly differentiated neuroendocrine lung cancers.
- Patients were stratified into chemotherapy-sensitive and chemotherapy-resistant groups based on relapse timing.
- Pemetrexed was administered at 500 mg/m² every 21 days, with folic acid, vitamin B12, and steroid prophylaxis.
Main Results:
- Twenty patients were enrolled in the chemotherapy-sensitive arm and 23 in the chemotherapy-resistant arm.
- Progressive disease was observed in 80% of the chemo-sensitive group and 83% of the chemo-resistant group.
- Minimal responses were noted, with one partial response and three stable disease cases in each group.
Conclusions:
- Pemetrexed demonstrates minimal single-agent activity in patients with relapsed SCLC.
- The study highlights the limited efficacy of pemetrexed in this patient population.
- Further investigation into alternative or combination therapies is warranted for advanced SCLC.
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