Cmelak Anthony J, Li Sigui, Goldwasser Meredith A, Murphy Barbara, Cannon Michael, Pinto Harlan, Rosenthal David I, Gillison Maura, Forastiere Arlene A
Vanderbilt University Medical Center, Nashville, TN 37232-5671, USA.
J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.
Taxane-based concurrent chemoradiotherapy (CCR) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation. This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx (OP) cancer patients.
Eligibility required resectable stage T2N+, or T3-T4N0-3M0 biopsy-proven squamous carcinoma, age at least 18 years, PS 0 to 2, good organ function, and no prior chemotherapy or radiation. Treatment was induction paclitaxel 175 mg/m(2) and carboplatin area under the concentration-time curve (AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m(2) every 7 days with 70 Gy if no evidence of tumor progression. Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin (< 14 gm/dL men, < 13 gm/dL women). The primary end point was organ preservation (freedom from primary site salvage surgery or primary tumor recurrence).
One hundred five of 111 patients (36 larynx, 69 OP) were eligible. Median follow-up was 36.7 months. Ninety-four percent received full-dose radiotherapy and 91% received at least five cycles of concurrent paclitaxel. No patient progressed while receiving chemotherapy. Organ preservation was 81% at 2 years after completion of therapy (larynx 74%, OP 84%). Thirteen patients required primary-site salvage surgery (seven larynx, six OP), and six of these have progressed and died (three larynx, three OP). Thirteen patients developed distant metastases (seven larynx, six OP; P = .02) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease. Two-year survival is 76% (63% larynx v 83% OP).
A high organ preservation rate was obtained with this regimen for OP but not for larynx patients. Toxicity was low, and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy.
与顺铂和放疗相比，基于紫杉烷的同步放化疗（CCR）已被证明对头颈部癌具有良好的毒性特征。这项II期多机构试验评估了基于紫杉烷的诱导化疗，随后进行CCR以保留可切除的III/IVA期和IVB期喉癌和口咽癌（OP）患者的器官。
入选标准为可切除的T2N+期或T3 - T4N0 - 3M0活检证实的鳞状癌，年龄至少18岁，体能状态（PS）为0至2，器官功能良好，且既往未接受过化疗或放疗。治疗方案为每21天进行两个周期的诱导化疗，使用紫杉醇175mg/m²和卡铂浓度 - 时间曲线下面积（AUC）6，随后若没有肿瘤进展证据，则每7天同步使用紫杉醇30mg/m²并给予70Gy放疗。对于血红蛋白水平欠佳（男性<14g/dL，女性<13g/dL）的患者，每周使用促红细胞生成素α 40kU。主要终点是器官保留（免于原发部位挽救性手术或原发肿瘤复发）。
111例患者中有105例（36例喉癌，69例口咽癌）符合条件。中位随访时间为36.7个月。94%的患者接受了全量放疗，91%的患者接受了至少五个周期的同步紫杉醇化疗。没有患者在接受化疗期间病情进展。治疗完成后2年时器官保留率为81%（喉癌74%，口咽癌84%）。13例患者需要进行原发部位挽救性手术（7例喉癌，6例口咽癌），其中6例病情进展并死亡（3例喉癌，3例口咽癌）。13例患者发生远处转移（7例喉癌，6例口咽癌；P = 0.02），36例喉癌患者中有10例、69例口咽癌患者中有11例因疾病死亡。两年生存率为76%（喉癌63%，口咽癌83%）。
该方案在口咽癌患者中获得了较高的器官保留率，但在喉癌患者中未达到。毒性较低，诱导化疗并不妨碍同步放化疗的实施。
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