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Promising overall survival of patients with recurrent/metastatic squamous cell carcinoma of head and neck receiving gemcitabine plus cisplatin treatment: report of a multi-center phase II study

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Abstract

Purpose

The efficacy and safety of gemcitabine in combination with cisplatin (GC) as the first-line treatment in patients with recurrent/metastatic (R/M) squamous cell carcinoma of head and neck (SCCHN) was examined.

Patients and methods

Patients with R/M SCCHN without prior treatment for their R/M disease were eligible and treated with gemcitabine 1,250 mg/m2 on day 1, day 8 and cisplatin 80 mg/m2 on day 8 every 21 days.

Results

Forty patients were enrolled from March 2004 to January 2006, and 30 were evaluable for treatment effectiveness and outcome. The median age of evaluable patients was 50 years and all patients were male. Partial response was observed in 9 (30%) and stable disease in 7 (23.3%) patients. The overall response rate and disease control rate was 30 and 53.3%, respectively. The major toxic effects were ≥grade 3 leukopenia and anemia (65 and 27.5%, respectively). With a follow-up of 72 months, the median time to progression (TTP) was 128 days (95% CI, 78–242) and median overall survival (OS) was 401 days (95% CI, 216 ~not reached).

Conclusions

This GC regimen demonstrates a good activity and a promising survival period in patients with R/M SCCHN.

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Acknowledgment

This study was sponsored by TTY Biopharm Co., Ltd. Taipei, Taiwan. Protocol No. TTYGM0301 and also partially supported by Taiwan Cancer Clinic Research Foundation.

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Authors and Affiliations

  1. Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan

    Muh-Hwa Yang

  2. Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan

    Peter Mu-Hsin Chang, Cheng-Hwai Tzeng, Shyue-Yih Chang, Pen-Yuan Chu, Shyh-Kuan Tai, Tung-Lung Tsai, Yi-Feng Wang, Jui-Lin Huang & Po-Min Chen

  3. Division of Hematology-Oncology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec 2, Shih-Pai Road, Taipei, 112, Taiwan

    Muh-Hwa Yang, Peter Mu-Hsin Chang, Cheng-Hwai Tzeng & Po-Min Chen

  4. Department of Otolaryngology, Taipei Veterans General Hospital, Taipei, Taiwan

    Shyue-Yih Chang, Pen-Yuan Chu, Shyh-Kuan Tai, Tung-Lung Tsai, Yi-Feng Wang & Jui-Lin Huang

  5. Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Lin-Kou Center, Taoyuan, Taiwan

    Hung-Ming Wang

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  1. Muh-Hwa Yang
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Correspondence to Hung-Ming Wang or Po-Min Chen.

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Yang, MH., Chang, P.MH., Tzeng, CH. et al. Promising overall survival of patients with recurrent/metastatic squamous cell carcinoma of head and neck receiving gemcitabine plus cisplatin treatment: report of a multi-center phase II study. Cancer Chemother Pharmacol 65, 259–265 (2010). https://doi.org/10.1007/s00280-009-1030-9

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  • DOI: https://doi.org/10.1007/s00280-009-1030-9

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