A phase II study of cisplatin and irinotecan as induction chemotherapy followed by accelerated hyperfractionated thoracic radiotherapy with daily low-dose carboplatin in unresectable stage III non-small cell lung cancer: JCOG 9510.

Abstract

OBJECTIVE:

It is important to find optimal regimens of cisplatin (CDDP)-based third-generation chemotherapy and radiotherapy for patients with unresectable Stage III non-small cell lung cancer (NSCLC).

METHODS:

This Phase II study was designed to determine the toxicity and efficacy of two courses of chemotherapy (CDDP 80 mg/m(2) on day 1 and irinotecan 60 mg/m(2) on days 1 and 8) followed by accelerated hyperfractionated thoracic radiotherapy (60 Gy/40 fractions in 4 weeks) combined with daily carboplatin (CBDCA) administration. CBDCA was administered at a target area under the plasma level-time curve of 0.4 x (24 h creatinine clearance + 25), according to Calvert's formula.

RESULTS:

Twenty-six patients were enrolled in the study. The patients' median age was 63 years (range 40-74 years) and included 22 males and 4 females. Seven patients were Stage IIIA and 19 were Stage IIIB. Twenty had a performance status (PS) of 1 versus six with a PS of 0. There was one treatment-related death due to sepsis and pneumonia associated with Grade 4 neutropenia and diarrhea during chemotherapy. Grade 3 or 4 neutropenia and diarrhea were observed in 14 and 5 patients, respectively. Toxicity of the radiotherapy was mild. There were 0 complete response and 13 partial responses, giving a response rate of 50.0%. Median survival time and 2-year survival were 16.4 months and 21.5%, respectively. This study was designed with Simon's two-stage design, and the response rate did not meet the criteria to proceed to the second stage and the study was terminated early.

CONCLUSIONS:

This regimen might be inactive for patients with unresectable Stage III NSCLC.

• Authors: Tomoki Fujii, Hiroshi Kunikane, Hiroaki Okamoto, Koshiro Watanabe, Hideo Kunitoh, Kiyoshi Mori, Akira Yokoyama, Haruhiko Fukuda, Tomohide Tamura, Nagahiro Saijo
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 39 Issue 12 Pg. 784-90 (Dec 2009) ISSN: 1465-3621 [Electronic] England
• PMID: 19770129 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Irinotecan
• Carboplatin
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic
• Antineoplastic Combined Chemotherapy Protocols
• Camptothecin (analogs & derivatives, therapeutic use)
• Carboplatin (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Combined Modality Therapy
• Drug Administration Schedule
• Female
• Humans
• Irinotecan
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Prognosis
• Radiotherapy Dosage
• Remission Induction
• Treatment Outcome