Six-week induction chemotherapy followed by concomitant chemoradiation therapy in stage IV head and neck cancer:: A phase II study with organ-sparing purposes

被引:0
作者
Mantovani, G
Massa, E
Astara, G
Murgia, V
Gramignano, G
Ferreli, L
Camboni, P
Lusso, MR
Mocci, M
Madeddu, C
Mura, L
Mudu, MC
Proto, E
Tore, G
Mura, M
Macciò, A
Ferreli, A
Amichetti, M
机构
[1] Univ Cagliari, Otolaryngol Branch, Dept Med Oncol, I-09124 Cagliari, Italy
[2] Univ Cagliari, Otolaryngol Branch, Dept Surg, I-09124 Cagliari, Italy
[3] SS Trinita Hosp, Div Otolaryngol, Cagliari, Italy
[4] Sirai Hosp, Div Obstet & Gynecol, Carbonia, Italy
[5] Lab Cyto & Histopathol Diag, Cagliari, Italy
[6] A Businco Hosp, Div Radiat Therapy, Cagliari, Italy
关键词
induction chemotherapy; chemoradiation therapy; organ-function preservation; head and neck cancer; stage IV;
D O I
暂无
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The purpose of the study was to assess response rate, clinical outcome, organ/function preservation and toxicity in head and neck cancer patients treated with induction chemotherapy followed by concomitant chemoradiotherapy and, when necessary, limited surgery. The study was a phase II non-randomized trial. Induction chemotherapy consisted of 6 weekly doses of carboplatin at AUC of 2 and docetaxel 30 mg/m(2) (1 h) followed by 5 cycles of docetaxel 25 mg/m(2)/day 1, 5-FU 600 mg/m(2) c.i. days 1-5, hydroxyurea 500 mg orally every 12 h for 11 and concomitant twice daily radiation therapy at 150 cGy/fraction given every other week per 5 cycles (TFHX), for a total radiation dose of 75 Gy. 13 cis-retinoic acid was administered for chemoprevention and systematic prophylaxis of mucositis with systemic amifostine and local GM-CSF was administered to all patients during TFHX. Conservative surgical resection was reserved to patients with no optimal response (PR greater than or equal to70%), whereas radical surgery was performed as salvage treatment. Thirteen patients (mean age 54.9 years, range 44-62; 12/13 site oropharynx, all stage IV) were enrolled: 31% of patients had ECOG performance status (PS) 0 and 69% had PS 1. Response to induction chemotherapy was analyzed in 12 patients: 2/12 (16.7%) achieved a partial response (PR) for an overall response (ORR) of 16.7%, 10/12 (83.3%) achieved stable disease (SD). TFHX was administered to 7 patients: 2 patients (28.6%) had complete remission (CR), 1 patient (14.3%) had PR for an ORR of 42.9%, 3 patients (42.8%) had SD and 1 patient (14.3%) had PD. At the completion of TFHX, 1 patient underwent local therapy. The toxicity was mild and consisted in: arade 3/4 neutropenia (7.7%), anemia (23.1%), diarrhea (15.4%), mucositis (7.7%), neurotoxicity (7.7%) during induction chemotherapy. During TFHX only 42.8% of grade 3/4 mucositis was observed. All patients spared organ/function. In conclusion, this regimen has been found feasible for its acceptable toxicity, particularly mucositis. However, the overall response rate and the data on survival were not satisfactory.
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页码:759 / 766
页数:8
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