Induction Chemotherapy Followed by Either Chemoradiotherapy or Bioradiotherapy for Larynx Preservation: The TREMPLIN Randomized Phase II Study

被引：294

作者：

Lefebvre, Jean Louis ^{[1
]}

Pointreau, Yoann ^{[3
]}

Rolland, Frederic ^{[4
]}

Alfonsi, Marc ^{[6
]}

Baudoux, Alain ^{[18
]}

Sire, Christian ^{[7
]}

de Raucourt, Dominique

Malard, Olivier ^{[5
]}

Degardin, Marian ^{[1
]}

Tuchais, Claude

Blot, Emmanuel ^{[9
]}

Rives, Michel ^{[10
]}

Reyt, Emile ^{[11
]}

Tourani, Jean Marc ^{[12
]}

Geoffrois, Lionel ^{[13
]}

Peyrade, Frederic ^{[14
]}

Guichard, Francois ^{[15
]}

Chevalier, Dominique ^{[2
]}

Babin, Emmanuel ^{[8
]}

Lang, Philippe ^{[16
]}

Janot, Francois ^{[17
]}

Calais, Gilles ^{[3
]}

Garaud, Pascal ^{[3
]}

Bardet, Etienne ^{[4
]}

机构：

[1] Ctr Oscar Lambret, F-59020 Lille, France

[2] Ctr Hosp Univ Claude Huriez, Lille, France

[3] Ctr Hosp Univ Pierre Bretonneau, Tours, France

[4] Inst Cancerol Ouest Rene Gauducheau, Nantes, France

[5] Ctr Hosp Univ Hotel Dieu, Nantes, France

[6] Inst Sainte Catherine, Avignon, France

[7] Ctr Hosp Bretagne Sud, Lorient, France

[8] Ctr Hosp Univ Cote Nacre, Caen, France

[9] Ctr Henri Becquerel, F-76038 Rouen, France

[10] Ctr Claudius Regaud, Toulouse, France

[11] Ctr Hosp Albert Michallon, Grenoble, France

[12] Ctr Hosp Univ Jean Bernard, Poitiers, France

[13] Ctr Alexis Vautrin, Nancy, France

[14] Inst Univ Face & Cou, Nice, France

[15] Polyclin Bordeaux Nord, Bordeaux, France

[16] Ctr Hosp Univ Pitie Salpetriere, Paris, France

[17] Inst Gustave Roussy, Villejuif, France

[18] Ctr Med Sainte Elisabeth, Namur, Belgium

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 31卷 / 07期

关键词：

SQUAMOUS-CELL CARCINOMA; DESIGN KEY ISSUES; NECK-CANCER; ORGAN PRESERVATION; TRIAL; HEAD; CISPLATIN; RADIOTHERAPY; DOCETAXEL; FLUOROURACIL;

D O I：

10.1200/JCO.2012.42.3988

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Purpose To compare the efficacy and safety of induction chemotherapy (ICT) followed by chemoradiotherapy (CRT) or bioradiotherapy (BRT) for larynx preservation (LP). Patients and Methods Previously untreated patients with stage III to IV larynx/hypopharynx squamous cell carcinoma received three cycles of ICT-docetaxel and cisplatin 75 mg/m(2) each on day 1 and fluorouracil 750 mg/m(2) per day on days 1 through 5. Poor responders (< 50% response) underwent salvage surgery. Responders (>= 50% response) were randomly assigned to conventional radiotherapy (RT; 70 Gy) with concurrent cisplatin 100 mg/m(2) per day on days 1, 22, and 43 of RT (arm A) or concurrent cetuximab 400 mg/m(2) loading dose and 250 mg/m(2) per week during RT (arm B). Primary end point was LP at 3 months. Secondary end points were larynx function preservation (LFP) and overall survival (OS) at 18 months. Results Of the 153 enrolled patients, 116 were randomly assigned after ICT (60, arm A; 56, arm B). Overall toxicity of both CRT and BRT was substantial following ICT. However, treatment compliance was higher in the BRT arm. In an intent-to-treat analysis, there was no significant difference in LP at 3 months between arms A and B (95% and 93%, respectively), LFP (87% and 82%, respectively), and OS at 18 months (92% and 89%, respectively). There were fewer local treatment failures in arm A than in arm B; salvage surgery was feasible in arm B only. Conclusion There is no evidence that one treatment was superior to the other or could improve the outcome reported with ICT followed by RT alone (French Groupe Oncologie Radiotherapie Tete et Cou [GORTEC] 2000-01 trial [Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma]). The protocol that can best compare with RT alone after ICT is still to be determined. J Clin Oncol 31:853-859. (C) 2013 by American Society of Clinical Oncology

引用

页码：853 / 859

页数：7

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