Background and Objective <p>Platinum-based chemotherapy remains the standard first-line treatment for extensive disease small cell lung carcinoma (ED-SCLC). However, therapeutic options in the second-line setting, particularly after disease progression on etoposide-cisplatin regimens, are limited. The combination of capecitabine and temozolomide (CAP-TEM) has shown activity in various neuroendocrine tumors, but evidence in ED-SCLC remains scarce. This real-world study aimed to evaluate the efficacy and safety of the CAP-TEM regimen in platinum-refractory ED-SCLC patients in a real-world tertiary care setting in Northern India.</p> Methods <p>This was a prospective interventional study conducted at Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, between June 2023 and December 2024. A total of 36 histopathologically confirmed ED-SCLC patients, who progressed after first-line etoposide-cisplatin chemotherapy and met predefined inclusion criteria, were enrolled. Patients received oral capecitabine (625 mg/m<sup>2</sup> twice daily, days 1–14) and temozolomide (150 mg/m<sup>2</sup> once daily, days 10–14) every 28 days for up to 6 cycles. Tumor response was assessed radiologically every 3 cycles. Safety assessments were based on CTCAE v5.0 criteria. Survival analysis was performed using Kaplan-Meier methods.</p> Results <p>Among 36 evaluable patients, the disease control rate (DCR) was 69.4% after 3 and 6 cycles, with 69.4% achieving stable disease and 30.6% showing progressive disease. The median progression-free survival (PFS) was 10 months. Subgroup analysis indicated a trend toward poorer outcomes in patients with brain metastases and prior radiotherapy. Most adverse events were grade 1 or 2; anemia, nausea, and hand-foot syndrome were the most common toxicities. No grade 3 or 4 toxicities were reported.</p> Conclusion <p>The CAP-TEM regimen demonstrated encouraging disease control with an acceptable safety profile in platinum-refractory ED-SCLC patients. These findings suggest CAP-TEM as a promising second-line option, meriting further evaluation in larger, biomarker-driven prospective studies.</p>

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Efficacy and Safety of Capecitabine-Temozolomide as Second-Line Therapy in Platinum-Refractory Extensive Disease Small Cell Lung Carcinoma (ED-SCLC): A Prospective Real-World Experience from Northern India

  • Deepak Agrawal,
  • Deepak Gupta,
  • Karamvir Yadav,
  • Nirmal Das Vaishnav,
  • Jay Kumar Sharma,
  • Mehul R. Chorawala

摘要

Background and Objective

Platinum-based chemotherapy remains the standard first-line treatment for extensive disease small cell lung carcinoma (ED-SCLC). However, therapeutic options in the second-line setting, particularly after disease progression on etoposide-cisplatin regimens, are limited. The combination of capecitabine and temozolomide (CAP-TEM) has shown activity in various neuroendocrine tumors, but evidence in ED-SCLC remains scarce. This real-world study aimed to evaluate the efficacy and safety of the CAP-TEM regimen in platinum-refractory ED-SCLC patients in a real-world tertiary care setting in Northern India.

Methods

This was a prospective interventional study conducted at Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, between June 2023 and December 2024. A total of 36 histopathologically confirmed ED-SCLC patients, who progressed after first-line etoposide-cisplatin chemotherapy and met predefined inclusion criteria, were enrolled. Patients received oral capecitabine (625 mg/m2 twice daily, days 1–14) and temozolomide (150 mg/m2 once daily, days 10–14) every 28 days for up to 6 cycles. Tumor response was assessed radiologically every 3 cycles. Safety assessments were based on CTCAE v5.0 criteria. Survival analysis was performed using Kaplan-Meier methods.

Results

Among 36 evaluable patients, the disease control rate (DCR) was 69.4% after 3 and 6 cycles, with 69.4% achieving stable disease and 30.6% showing progressive disease. The median progression-free survival (PFS) was 10 months. Subgroup analysis indicated a trend toward poorer outcomes in patients with brain metastases and prior radiotherapy. Most adverse events were grade 1 or 2; anemia, nausea, and hand-foot syndrome were the most common toxicities. No grade 3 or 4 toxicities were reported.

Conclusion

The CAP-TEM regimen demonstrated encouraging disease control with an acceptable safety profile in platinum-refractory ED-SCLC patients. These findings suggest CAP-TEM as a promising second-line option, meriting further evaluation in larger, biomarker-driven prospective studies.