Irinotecan and oxaliplatin combination as the first-line treatment for patients with advanced non-small cell lung cancer

Abstract

BackgroundWe conducted a prospective phase II trial of IrOx in patients with advanced non-small cell lung cancer to evaluate the efficacy
and toxicity.

Patients and methodsPatients with histologically or cytologically proven non-small cell lung cancer (NSCLC), aged ≥18 years, Eastern Cooperative
Oncology Group performance status 0–1, at stage IIIB (pleural effusion)/IV or with recurrent disease not suitable for primary
surgical treatment, with no palliative chemotherapy or radiotherapy to the chest or immunotherapy or biologic therapy, the
presence of measurable disease by RECIST, and who had given signed written informed consent, were eligible. Treatment consisted
of irinotecan 65 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 1, repeated every 3 weeks.

ResultsA total of 18 patients were enrolled in June and August 2007, the median age was 59 years (47–73). In total, 71 cycles were
administered with a median of 4 cycles per patient (range, 1–6 cycles) and 18 patients were evaluable for treatment response.
An independent review of tumor responses gave an overall response rate of 27.7% (CR: 0, PR: 5/18; 95% CI, 7–48.4%) by intent-to-treat
analysis. The median overall survival of all patients was 14 months and the median time-to-progression was 4.2 months (95%
CI, 1.959–6.441). The most common grade 3/4 toxicities were diarrhea (7% of all cycles) and neutropenia (5.6% of all cycles).
Grade 3 peripheral neuropathy occurred in one patient and one patient died due to sepsis.

ConclusionThis study suggests that IrOx combination therapy has moderate activity with a tolerable toxicity profile. However, it was
not warranted to evaluate further this regimen as first-line treatment for patients with advanced or metastatic NSCLC using
the current dosages and schedule.