Phase II Study of Gemcitabine and Docetaxel Combination in Patients with Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. (10th May 2012)

• Record Type: Journal Article
• Authors: Kafri, Zyad; Heilbrun, Lance K.; Sukari, Ammar; Yoo, George; Jacobs, John; Lin, Ho-Sheng; Mulrenan, Heather; Smith, Daryn; Kucuk, Omer
• Other Names: Emoto M. Academic Editor.; Santarosa M. Academic Editor.
• Is Part Of: ISRN oncology. Volume 2012(2012)
• Publication Date: 2012-05-10
• Subjects: Oncology -- Periodicals; Neoplasms; Oncology; Periodicals; 616.994
• DOI: 10.5402/2012/159568
• Languages: English
• ISSNs: 2090-5661

Abstract

Abstract : Purpose . To explore the safety and efficacy of gemcitabine and docetaxel (GEMDOC) in previously treated patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods . Patients with advanced SCCHN previously pretreated with one or two lines of palliative chemotherapy were treated with gemcitabine and docetaxel until disease progression. Results . Thirty-six patients were enrolled, and 29 were response evaluable. 16 (55%) experienced clinical benefit (response or stable disease). Six (21%) patients achieved partial response (PR), none achieved complete response (CR), and the overall response rate (ORR) was 21% (95% CI: 0.10–0.38). Ten (28%) patients had stable disease. The median response duration (RD) for the 6 PR patients was 3.2 months (80% CI: 2.0–6.1 months). Median overall survival was 4.2 months (95% CI: 2.4–7.0 months). Among the 33 treated patients: 13 (39%) patients had grade 3-4 anemia, 10 (30%) had grade 3-4 neutropenia. Conclusion . The study drugs were relatively safe, and the clinical benefit (PR + SD) rate was 55%. However, the efficacy objective for this regimen was not met. Given the good safety profile, further investigation of this regimen with the addition of a targeted agent may lead to better efficacy.