Annals of Oncology Advance Access originally published online on October 15, 2007
Annals of Oncology 2008 19(1):115-122; doi:10.1093/annonc/mdm430
lung cancer |
Paclitaxel and gemcitabine versus carboplatin and gemcitabine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group
1 Department of Medical Oncology, Hygeia Hospital, Athens
2 Division of Oncology, University Hospital of Patras, Patras
3 2nd Department of Medical Oncology, Henry Dunant Hospital, Athens
4 Oncology Unit, 3rd Department of Medicine, Athens Medical School, Sotiria General Hospital, University of Athens, Athens
5 Department of Medical Oncology, University of Ioannina School of Medicine, Ioannina
6 Department of Medical Oncology, Metropolitan Hospital, Piraeus
7 Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens
8 3rd Department of Medical Oncology, Agii Anargiri Cancer Hospital, University of Ioannina, Athens
9 2nd Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon, Athens
10 Department of Medical Oncology, Theagenio Hospital, University of Athens Thessaloniki
11 Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece
* Correspondence to: Dr P. A. Kosmidis, Hygeia Hospital, 2 An Tsoha & Vas Sofias Avenue, Athens 11521, Greece. Tel: +30 21-645-8602; Fax: +30 21-645-2616; E-mail: parkosmi{at}otenet.gr
Background: This phase III study was designed to compare the combination paclitaxel (Taxol)–gemcitabine (PG) versus carboplatin–gemcitabine (CG) in patients with advanced inoperable non-small-cell lung cancer.
Methods: Chemotherapy-naive patients with performance status of zero or one were randomized to gemcitabine 1 gm/m2 on days 1 and 8 plus either paclitaxel 200 mg/m2 on day 1 (arm A) or carboplatin at an area under the concentration–time curve of 6 mg on day 1 (arm B) every 3 weeks. Primary end point was overall survival (OS). Secondary end points included objective response (OR), time to progression and toxicity.
Results: A total of 512 patients were enrolled and 452 eligible (arm A, 225; arm B, 227) were analyzed. All characteristics were well balanced with the exception of vena cava obstruction symptoms and lymph node involvement. Median survival was 9.97 months [95% confidence interval (CI) 8.74–12.0] for group A and 10.49 (95% CI 9.04–11.94) for group B. There was no difference in the OS, 1-year survival, OR and TtP. However, statistically significant differences were seen in toxicity.
Conclusion: The two regimens are equally active. Myelotoxicity is worse in the CG group whereas alopecia, myalgia and neurotoxicity worse in the PG group.
Key words: carboplatin, chemotherapy, gemcitabine, non-small-cell lung cancer, paclitaxel
Received for publication May 17, 2007. Revision received July 24, 2007. Accepted for publication July 24, 2007.
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