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

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 c...

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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
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Summary:	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.
Bibliography:	ark:/67375/WNG-R85GQF8W-J ArticleID:AJCO1193 istex:5E98D6C512DD6B137ACF9C1E14C9E24A6EFF8813 St George Hospital Cancer Centre, Sydney, NSW, Australia. Present address Covance, Sydney, NSW, Australia. Newcastle Mater Misericordiae Hospital, Newcastle, NSW, Australia. Abraxis Bioscience, Ontario, Canada. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1743-7555 1743-7563
DOI:	10.1111/j.1743-7563.2009.01193.x