Randomized phase II trial of gemcitabine and either day 1 or day 8 carboplatin for advanced non-small-cell lung cancer: Is thrombocytopenia predictable?

• Published in: Asia-Pacific journal of clinical oncology Vol. 5; no. 1; pp. 24 - 31
• Main Authors: CROMBIE, Cathy, BURNS, W Ivon, KARAPETIS, Christos, LOWENTHAL, Ray M, KIRSTEN, Fred, DAVIDSON, J Andrew, ABELL, Fiona, REECE, William HH, IGLESIAS, Jose, DE SOUZA, Paul
• Format: Journal Article
• Language: English
• Published: Melbourne, Australia Blackwell Publishing Asia 01.03.2009
• Subjects: carboplatin; gemcitabine; non-small cell lung cancer; thrombocytopenia; toxicity prediction
• ISSN: 1743-7555; 1743-7563
• DOI: 10.1111/j.1743-7563.2009.01193.x

Aim:  Two 21‐day gemcitabine–carboplatin schedules were evaluated in patients with advanced non‐small cell lung cancer in order to assess the effect of timing of the carboplatin dose on toxicity and efficacy. Methods:  Patients were randomized to gemcitabine (1000 mg/m2 on days 1 and 8 of a 21‐day cycle) and carboplatin (AUC 5, on day 1) (Carbo d1 arm) or the same gemcitabine schedule with carboplatin given on day 8 (Carbo d8 arm). Twenty patients with Stage IIIB or IV non‐small‐cell lung cancer were enrolled in each arm. Results:  The achieved dose intensities of both gemcitabine and carboplatin were significantly higher in the Carbo d1 arm. The total rates of grade 3 or 4 hematological and non‐hematological toxicities (any toxicity, any cycle) were 80% and 65%, respectively, with no significant differences between the two arms. Nine patients in the Carbo d1 arm, but only one patient in the Carbo d8 arm, required a platelet transfusion. There were 10 partial responses (four Carbo d1 arm, six Carbo d8 arm), giving an overall response rate of 25% (95% CI 13–41%). Conclusion:  Administration of carboplatin on day 8 of this regimen confers no clear advantage compared with day 1 carboplatin, with similar toxicity but lower dose intensity. A formula for the prediction of thrombocytopenia is proposed.