title: The efficacy and toxicity of S-1 and cisplatin as first-line chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma.
abstract: OBJECTIVE
  To assess the clinical activity and toxicity of a combination chemotherapy regimen of S-1 and cisplatin in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) in a retrospective study.
  
  
  METHODS
  A total of 49 patients were treated in an outpatient setting with S-1 80 mg/m(2) on days 1-14 and with cisplatin 70 mg/m(2) on day 1 every 3 weeks for a maximum of six cycles as a first-line palliative chemotherapy. Patients who achieved complete response (CR), partial response (PR) or stable disease (SD) after six cycles received S-1 monotherapy as a maintenance therapy.
  
  
  RESULTS
  The median patient age was 55 years (range 33-79), 89.8 % were male, and the Eastern Cooperative Oncology Group performance status distribution was 0/1/2 (20.4 %/73.5 %/6.1 %). Of the 43 evaluable patients, 2 (4.1 %) achieved CR and 20 (40.8 %) had a PR, for an overall response rate of 44.9 %. Thirteen patients (26.6 %) had SD. The median number of chemotherapy treatments was 4 (range 1-18). Nine patients received maintenance S-1 monotherapy after six cycles of combination chemotherapy. With a mean 10.5 months (range 1.3-25.1) of follow-up, the median progression-free and overall survival were 4.5 (95 % CI, 3.7-5.3 months) and 10.8 months (95 % CI, 5.9-15.6 months), respectively. The main grade 3-4 toxicities were neutropenia (37 %), anemia (16 %) and general weakness (8 %). Other toxicities, including nausea/vomiting, mucositis and neuropathy, were mostly grade 1-2 and easily manageable.
  
  
  CONCLUSIONS
  The combination of S-1/cisplatin therapy had a favorable efficacy with manageable toxicity as a first-line chemotherapy regimen for advanced head and neck squamous cell carcinoma patients.
authors.affiliation: Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seodaemun-gu, Seoul, South Korea.
authors.forename: Han Sang
authors.initials: HS
authors.lastname: Kim
authors.forename: Hye Ryun
authors.initials: HR
authors.lastname: Kim
authors.forename: Gun Min
authors.initials: GM
authors.lastname: Kim
authors.forename: Hyo Song
authors.initials: HS
authors.lastname: Kim
authors.forename: Yoon Woo
authors.initials: YW
authors.lastname: Koh
authors.forename: Se Hun
authors.initials: SH
authors.lastname: Kim
authors.forename: Eun Chang
authors.initials: EC
authors.lastname: Choi
authors.forename: Yun Kyoung
authors.initials: YK
authors.lastname: Hong
authors.forename: Ji Hee
authors.initials: JH
authors.lastname: Sung
authors.forename: Sun Mi
authors.initials: SM
authors.lastname: Kim
authors.forename: Joo Hang
authors.initials: JH
authors.lastname: Kim
authors.forename: Byoung Chul
authors.initials: BC
authors.lastname: Cho
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D000077195:Squamous Cell Carcinoma of Head and Neck; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin