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

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Abstract

Background

We 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 methods

Patients 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.

Results

A 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.

Conclusion

This 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.

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Acknowledgments

We acknowledge the Pfizer Pharmaceuticals Korea Ltd. who generously donated irinotecan for the study.

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Authors and Affiliations

  1. Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Seoul, South Korea

    Myung Hee Chang, Kyoung Ha Kim, Hyun Jung Jun, Hyo Song Kim, Seong Yoon Yi, Ji Eun Uhm, Min Jae Park, Do Hyoung Lim, Sang Hoon Ji, Jeeyun Lee, Yeon Hee Park, Jin Seok Ahn, Myung-ju Ahn & Keunchil Park

  2. Division of Hematology-Oncology, Department of Medicine, Chung-Ang University Young San Hospital, Seoul, South Korea

    In Gyu Hwang

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  1. Myung Hee Chang
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Correspondence to Keunchil Park.

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Chang, M.H., Kim, K.H., Jun, H.J. et al. Irinotecan and oxaliplatin combination as the first-line treatment for patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol 64, 917–924 (2009). https://doi.org/10.1007/s00280-009-0943-7

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