Efficacy and safety of dose-modified docetaxel plus cisplatin-based induction chemotherapy in Asian patients with locally advanced head and neck cancer.

The beneficial effects of docetaxel plus cisplatin-based induction chemotherapy for patients with unresectable, advanced head and neck cancer (HNC) have been documented in Western countries. However, the efficacy of such treatment has not been confirmed in Asian patients. We aimed to determine whether incorporation of dose-modified docetaxel into a cisplatin-based induction regimen would be both effective and tolerable in our Asian population of patients. Thirty-six patients with stage III or IV HNC who had undergone cisplatin-based induction chemotherapy were included in the current analysis. Fifty-three percentage of the patients had received induction chemotherapy with bolus cisplatin and continuous 5-fluorouracil (PF group), while the remaining 47% had additionally received dose-modified docetaxel (TPF group). We assessed the relative impact of the two treatments on clinical outcomes and treatment-related toxicities. The disease control rate was higher in the TPF group (92·9% vs. 76·5%), although the difference did not reach statistical significance (P = 0·217). Addition of docetaxel increased the median progression-free survival to 435 days, which was 2·3 times longer than that (188 days) of patients not receiving docetaxel (P = 0·019). Non-haematological toxicity profile was similar and acceptable in both treatment groups. Higher incidence of grade 3/4 neutropenia and more episodes of neutropenic fever-related hospitalization occurred in the docetaxel-treated patients, but most of them were managed uneventfully. Addition of dose-modified docetaxel to cisplatin-based induction chemotherapy was both efficacious and generally safe. Docetaxel addition significantly prolonged progression-free survival and had an acceptable safety profile in our Asian population of patients with locoregionally advanced HNC.

Huang CE ，Lu CH ，Chen PT ，Chan CH ，Chen WC ，Wang WH ，Wu JY ，Kuan FC ，Lee KD ，Chen CC ... -  《-》

Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer.

Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival. A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P=0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P=0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group. As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888 [ClinicalTrials.gov].).

Vermorken JB ，Remenar E ，van Herpen C ，Gorlia T ，Mesia R ，Degardin M ，Stewart JS ，Jelic S ，Betka J ，Preiss JH ，van den Weyngaert D ，Awada A ，Cupissol D ，Kienzer HR ，Rey A ，Desaunois I ，Bernier J ，Lefebvre JL ，EORTC 24971/TAX 323 Study Group ... -  《-》

Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer.

A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy. We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival. With a minimum of 2 years of follow-up (> or =3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P=0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P=0.006). There was better locoregional control in the TPF group than in the PF group (P=0.04), but the incidence of distant metastases in the two groups did not differ significantly (P=0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group. Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546 [ClinicalTrials.gov].).

Posner MR ，Hershock DM ，Blajman CR ，Mickiewicz E ，Winquist E ，Gorbounova V ，Tjulandin S ，Shin DM ，Cullen K ，Ervin TJ ，Murphy BA ，Raez LE ，Cohen RB ，Spaulding M ，Tishler RB ，Roth B ，Viroglio Rdel C ，Venkatesan V ，Romanov I ，Agarwala S ，Harter KW ，Dugan M ，Cmelak A ，Markoe AM ，Read PW ，Steinbrenner L ，Colevas AD ，Norris CM Jr ，Haddad RI ，TAX 324 Study Group ... -  《-》

Randomized controlled phase II comparison study of concurrent chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil versus CCRT with cisplatin, 5-fluorouracil, methotrexate and leucovorin in patients with locally advanced squamous cell carcinoma

Tsukuda M ，Ishitoya J ，Matsuda H ，Horiuchi C ，Taguchi T ，Takahashi M ，Nishimura G ，Kawakami M ，Watanabe M ，Niho T ，Kawano T ，Ikeda Y ，Sakuma Y ，Shiono O ，Komatsu M ... -  《-》

Adjuvant docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced squamous cell carcinoma of the head and neck.

Baghi M ，Hambek M ，May A ，Radeloff A ，Gstoettner W ，Knecht R ... -  《ANTICANCER RESEARCH》