| Abstract | BACKGROUND: Few clinical phase II studies using non-platinum doublet as adjuvant chemotherapy following complete resection of non-small-cell lung cancer (NSCLC) have been published, so this clinical study was designed to evaluate the toxicity profile and efficacy of the non-platinum doublet of docetaxel (DOC) + gemcitabine (GEM). METHODS: Eligibility criteria included completely resected NSCLC, pathological stage II or IIIA, younger than 76 years old, and performance status 0-1. Treatment consisted of DOC 60 mg/m2 on day 8, and GEM 1,000 mg/m2 on days 1, 8, and 15 every 4 weeks (4 cycles). The GEM dosage was decreased to 800 mg/m2 after the initial 21 patients because 3 patients developed interstitial lung disease (ILD). RESULTS: Thirty-five patients (male/female 21/14) were enrolled. The median age was 62 years (range 47-74), with five (14.3%) over the age of 70. Performance status was 0 in 34 patients. The diagnosis was ad in 28 patients, sq in 6, and adsq in 1. The pathological stage was IIA in 5 patients, IIB in 1 and stage IIIA in 29 (82.9%). All patients underwent at least one cycle of chemotherapy, with 29 patients completing three cycles of chemotherapy and 23 (66%) had four cycles. The main grade 3/4 toxicities comprised neutropenia (n = 21, 60%), thrombocytopenia (n = 3, 8.6%), anorexia (n = 4, 11.4%), and ILD (n = 3, 8.6%), which responded well to corticosteroids. There were no treatment-related deaths. The 4-year recurrence-free survival rate was 42.9%, and the 4-year survival rate was 65.8%. CONCLUSIONS: The non-platinum doublet regimen of DOC + GEM as adjuvant chemotherapy following complete resection of NSCLC is feasible, with good compliance, the only problem being ILD. |
| Authors | Masafumi Kawamura, Keisuke Eguchi, Yotaro Izumi, Yasushi Yamato, Teruaki Koike, Hirozo Sakaguchi, Enjo Hada, Koichi Kobayashi
(Affiliation: Division of General Thoracic Surgery, Keio University Hospital, 35 Shinanomachi, Tokyo 160-8582, Japan. kawamura at sc.itc.keio.ac.jp)
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| Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 60
Issue 4
Pg. 495-501
(Sep 2007)
ISSN: 0344-5704 Germany |
| PMID | 17143600
(Publication Type: Clinical Trial, Phase II, Journal Article)
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| Chemical References |
- Taxoids
- gemcitabine
- docetaxel
- Deoxycytidine
|
| Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
- Carcinoma, Non-Small-Cell Lung
(drug therapy, surgery)
- Chemotherapy, Adjuvant
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives)
- Drug Administration Schedule
- Female
- Humans
- Lung Neoplasms
(drug therapy, surgery)
- Male
- Middle Aged
- Neutropenia
(chemically induced)
- Survival Rate
- Taxoids
(administration & dosage, adverse effects)
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