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Phase II trial of edatrexate in small cell lung cancer
M Wiesenfeld1, J R Jett, J Q Su
1Cedar Rapids Oncology Project Community Clinical Oncology Program, Iowa.
Background:
Long-term survival with extensive stage small cell lung cancer is rare. There have been no major advances in the treatment of this stage of disease in the last 15-20 years. New agents with activity against this malignancy are needed. This study was designed to evaluate the efficacy of edatrexate against small cell lung cancer in a Phase II trial.
Methods:
This was a multicenter cooperative oncology group trial. Patients were either previously untreated or had failed only one prior chemotherapy regimen. All previously untreated patients had extensive stage disease. Patients in whom prior therapy had been unsuccessful had either limited or extensive stage disease. All cases had histologic documentation. Patients received edatrexate (80 mg/m2) intravenously over 20-30 minutes every 7 days. Previously untreated patients with disease progression at any time or stable disease after 6 weeks of treatment were crossed over to treatment with cisplatin and etoposide. The primary end points of the study were clinical response and toxicity to edatrexate. All patients were observed for survival.
Results:
Eleven previously untreated and 22 previously treated patients were enrolled. A median of five doses of chemotherapy was given to each group. No major clinical response was observed in either group. The median survival time for the 11 previously untreated patients was 9.8 months versus 3.7 months for individuals who had received prior therapy. Myelosuppression and stomatitis were the primary toxicities, and both were infrequent.
Conclusions:
Edatrexate is inactive against small cell lung cancer.
Insights
Edatrexate showed no efficacy in treating extensive stage small cell lung cancer. This Phase II trial found no clinical response, indicating the need for new small cell lung cancer treatments.
Area of Science:
- Oncology
- Medical Oncology
- Clinical Trials
Background:
- Extensive stage small cell lung cancer (SCLC) has poor long-term survival rates.
- Limited treatment advancements for SCLC in the past 15-20 years necessitate novel therapeutic agents.
- This study investigated edatrexate for SCLC due to the need for new active agents.
Purpose of the Study:
- To evaluate the clinical efficacy and toxicity of edatrexate in patients with small cell lung cancer.
- To assess response rates and survival outcomes in both previously untreated and treated SCLC patients.
Main Methods:
- A multicenter cooperative oncology group Phase II trial.
- Patients received edatrexate (80 mg/m2) intravenously weekly.
- Eligibility included previously untreated or one-prior-chemotherapy-regimen patients with SCLC.
Main Results:
- No major clinical response to edatrexate was observed in either previously untreated or treated SCLC patients.
- Median survival was 9.8 months for previously untreated patients and 3.7 months for previously treated patients.
- Myelosuppression and stomatitis were the main toxicities and occurred infrequently.
Conclusions:
- Edatrexate demonstrates inactivity against small cell lung cancer.
- The study did not identify a role for edatrexate in SCLC treatment.
- Further research into novel agents for SCLC is warranted.