Prospective Phase II Open-Label Randomized Controlled Trial to Compare Mandibular Preservation in Upfront Surgery With Neoadjuvant Chemotherapy Followed by Surgery in Operable Oral Cavity Cancer

被引:31
作者
Chaukar, Devendra [1 ]
Prabash, Kumar [2 ]
Rane, Pawan [3 ]
Patil, Vijay Maruti [2 ]
Thiagarajan, Shivakumar [1 ]
Ghosh-Laskar, Sarbani [4 ,5 ]
Sharma, Shilpi [6 ]
Pai, Prathamesh S. [1 ]
Chaturvedi, Pankaj [1 ]
Pantvaidya, Gouri [1 ]
Deshmukh, Anuja [1 ]
Nair, Deepa [1 ]
Nair, Sudhir [1 ]
Vaish, Richa [1 ]
Noronha, Vanita [2 ]
Patil, Asawari [5 ]
Arya, Supreeta [7 ]
D'Cruz, Anil [8 ]
机构
[1] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Head & Neck Surg Oncol, Mumbai 400012, Maharashtra, India
[2] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Med Oncol, Mumbai, Maharashtra, India
[3] Healthway Hosp, Kadamba Plateau, Goa, India
[4] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Radiat Oncol, Mumbai, Maharashtra, India
[5] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Pathol, Mumbai, Maharashtra, India
[6] Narayana Superspecial Hosp, Gurugram, India
[7] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Radiol, Mumbai, Maharashtra, India
[8] Apollo Hosp, Dept Oncol, Mumbai, Maharashtra, India
关键词
QUALITY-OF-LIFE; INDUCTION CHEMOTHERAPY; ADVANCED HEAD; NECK-CANCER; FLUOROURACIL; DOCETAXEL; CISPLATIN; COMPLICATIONS; CARCINOMA; RADIATION;
D O I
10.1200/JCO.21.00179
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSE The objective of this study was to explore the potential role and safety of neoadjuvant chemotherapy (NACT) in tumor shrinkage and resultant mandibular preservation in oral cancers compared with conventional surgical treatment. METHODS This study was a single-center, randomized, phase II trial of treatment-naive histologically confirmed squamous cell carcinoma of the oral cavity with cT2-T4 and N0/N+, M0 (American Joint Committee on Cancer, seventh edition) stage, necessitating resection of the mandible for paramandibular disease in the absence of clinicoradiologic evidence of bone erosion. The patients were randomly assigned (1:1) to either upfront surgery (segmental resection) followed by adjuvant treatment (standard arm [SA]) or two cycles of NACT (docetaxel, cisplatin, and fluorouracil) at 3-week intervals (intervention arm [IA]), followed by surgery dictated by postchemotherapy disease extent. All patients in the IA received adjuvant chemoradiotherapy, and patients in the SA were treated as per final histopathology report. The primary end point was mandible preservation rate. The secondary end points were disease-free survival and treatment-related toxicity. RESULTS Sixty-eight patients were enrolled over 3 years and randomly assigned to either SA (34 patients) or IA (34 patients). The median follow-up was 3.6 years (interquartile range, 0.95-7.05 years). Mandibular preservation was achieved in 16 of 34 patients (47% [95% CI, 31.49 to 63.24]) in the IA. The disease-free survival (P = .715, hazard ratio 0.911 [95% CI, 0.516 to 1.607]) and overall survival (P = .747, hazard ratio 0.899 [95% CI, 0.510 to 1.587]) were similar in both the arms. Complications were similar in both arms, but chemotherapy-induced toxicity was observed in the majority of patients (grade III: 14, 41.2%; grade IV: 11, 32.4%) in the IA. CONCLUSION NACT plays a potential role in mandibular preservation in oral cancers with acceptable toxicities and no compromise in survival. However, this needs to be validated in a larger phase III randomized trial.
引用
收藏
页码:272 / +
页数:12
相关论文
共 28 条
  • [1] Quality of life in oral cancer patients - Effects of mandible resection and socio-cultural aspect's
    Becker, Stephan T.
    Menzebach, Marc
    Kuechler, Thomas
    Hertrampf, Katrin
    Wenz, Hans-Juergen
    Wiltfang, Joerg
    [J]. JOURNAL OF CRANIO-MAXILLOFACIAL SURGERY, 2012, 40 (01) : 24 - 27
  • [2] Making Advances in Quality of Life Studies in Head and Neck Cancer
    Bjordal, Kristin
    Bottomley, Andrew
    [J]. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2017, 97 (04): : 659 - 661
  • [3] Invasion of the mandible in gingivobuccal complex cancers: Histopathological analysis of routes of tumour entry and correlation with preoperative assessment
    Chaukar, D. A.
    Dandekar, M.
    Kane, S.
    Arya, S.
    Purandare, N.
    Rangarajan, V
    D'Cruz, A. K.
    [J]. ORAL ONCOLOGY, 2018, 86 : 181 - 187
  • [4] Incidence and impact of Dihydropyrimidine dehydrogenase gene mutation on neoadjuvant chemotherapy in head and neck cancers
    Chougule, Anuradha
    Patil, Vijay M.
    Noronha, Vanita
    Joshi, Amit
    Turkkar, Siddharth
    Chandrasekharan, Arun
    Pande, Nikhil
    Bagayatkar, Priyanka
    Prabhash, Kumar
    [J]. ORAL ONCOLOGY, 2017, 70 : 73 - 74
  • [5] Classification of surgical complications - A new proposal with evaluation in a cohort of 6336 patients and results of a survey
    Dindo, D
    Demartines, N
    Clavien, PA
    [J]. ANNALS OF SURGERY, 2004, 240 (02) : 205 - 213
  • [6] Definitive chemoradiation for locally-advanced oral cavity cancer: A 20-year experience
    Foster, Corey C.
    Melotek, James M.
    Brisson, Ryan J.
    Seiwert, Tanguy Y.
    Cohen, Ezra E. W.
    Stenson, Kerstin M.
    Blair, Elizabeth A.
    Portugal, Louis
    Gooi, Zhen
    Agrawal, Nishant
    Vokes, Everett E.
    Haraf, Daniel J.
    [J]. ORAL ONCOLOGY, 2018, 80 : 16 - 22
  • [7] Randomized Trial Comparing Surgery and Adjuvant Radiotherapy Versus Concurrent Chemoradiotherapy in Patients With Advanced, Nonmetastatic Squamous Cell Carcinoma of the Head and Neck: 10-Year Update and Subset Analysis
    Iyer, N. Gopalakrishna
    Tan, Daniel S. W.
    Tan, Veronique K. M.
    Wang, Weining
    Hwang, Jacqueline
    Tan, Ngian-Chye
    Sivanandan, Ranjiv
    Tan, Hiang-Khoon
    Lim, Wan Teck
    Ang, Mei-Kim
    Wee, Joseph
    Soo, Khee-Chee
    Tan, Eng Huat
    [J]. CANCER, 2015, 121 (10) : 1599 - 1607
  • [8] Comparison of postoperative complications in advanced head and neck cancer patients receiving neoadjuvant chemotherapy followed by surgery versus surgery alone
    Joshi, Poonam
    Joshi, Amit
    Prabhash, Kumar
    Noronha, Vanita
    Chaturvedi, Pankaj
    [J]. INDIAN JOURNAL OF MEDICAL AND PAEDIATRIC ONCOLOGY, 2015, 36 (04) : 249 - 254
  • [9] Larynx preservation in pyriform sinus cancer: Preliminary results of a European organization for research and treatment of cancer phase III trial
    Lefebvre, JL
    Chevalier, D
    Luboinski, B
    Kirkpatrick, A
    Collette, L
    Sahmoud, T
    [J]. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1996, 88 (13) : 890 - 899
  • [10] Primary chemotherapy in resectable oral cavity squamous cell cancer:: A randomized controlled trial
    Licitra, L
    Grandi, C
    Guzzo, M
    Mariani, L
    Lo Vullo, S
    Valvo, F
    Quattrone, P
    Valagussa, P
    Bonadonna, G
    Molinari, R
    Cantù, G
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (02) : 327 - 333