Phase 3 RCT comparing docetaxel-platinum with docetaxel-platinum-5FU as neoadjuvant chemotherapy in borderline resectable oral cancer

Neoadjuvant chemotherapy (NACT) with TPF (docetaxel, cisplatin, and 5FU) is one of the treatment options in very locally advanced oral cancer with a survival advantage over PF (cisplatin and 5FU). TP (docetaxel and cisplatin) has shown promising results with a lower rate of adverse events but has ne...

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Published in:	European journal of cancer (1990) Vol. 200; p. 113560
Main Authors:	Noronha, Vanita, Patil, Vijay, Chaturvedi, Pankaj, Mathrudev, Vijayalakshmi, Menon, Nandini, Bhattacharjee, Atanu, Singh, Ajay, Peelay, Zoya, Chakraborty, Shatabdi, Jadhav, Monica, Alone, Mitali, Bhagyavant, Priyanka, Kolkur, Manali, Srinivas, Sujay, Das, Sudeep, Roy, Somnath, Mandal, Tanmoy, Dsouza, Hollis, Saha, Saswata, Rai, Rahul, Srikanth, Anne, Shah, Darshit, Khan, Arif, Muthuluri, Hemanth, Kumar, Amit, Agarwal, Amit, Rajpurohit, Anu, Goli, Vasu Babu, Sekar, Anbarasan, Mantri, Anoop, Kanteti, Aditya Pavan Kumar, Majumdar, Swaratika, Khaddar, Satvik, Shenoy, Ramnath, Elamarthi, Prahlad, Rathnasamy, Narmadha, Kashyap, Lakhan, Abraham, George, Booma, Naveen, Simha, Vijay, Chaukar, Devendra, Pai, Prathamesh, Nair, Sudhir, Laskar, Sarbani, Nawale, Kavita, Naidu, Priyanka, Salian, Sushmita, Shelar, Priyanka, Raulo, Ravinarayan, Dhumal, Sachin Babanrao, Prabhash, Kumar
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-03-2024
Subjects:	Borderline resectable Head and Neck Cancer Induction chemotherapy Neoadjuvant chemotherapy Oral Cancer Technically unresectable Neoadjuvant chemotherapy Head and Neck Cancer Oral Cancer Induction chemotherapy Borderline resectable Technically unresectable
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Summary:	Neoadjuvant chemotherapy (NACT) with TPF (docetaxel, cisplatin, and 5FU) is one of the treatment options in very locally advanced oral cancer with a survival advantage over PF (cisplatin and 5FU). TP (docetaxel and cisplatin) has shown promising results with a lower rate of adverse events but has never been compared to TPF. In this phase 3 randomized superiority study, adult patients with borderline resectable locally advanced oral cancers were randomized in a 1:1 fashion to either TP or TPF. After the administration of 2 cycles, patients were evaluated in a multidisciplinary clinic and further treatment was planned. The primary endpoint was overall survival (OS) and secondary endpoints were progression-free survival (PFS) and adverse events. 495 patients were randomized in this study, 248 patients in TP arm and 247 in TPF arm. The 5-year OS was 18.5% (95% CI 13.8–23.7) and 23.9% (95% CI 18.1-30.1) in TP and TPF arms, respectively (Hazard ratio 0.778; 95% CI 0.637–0.952; P = 0.015). Following NACT, 43.8% were deemed resectable, but 34.5% underwent surgery. The 5-year OS was 50.7% (95% CI 41.5–59.1) and 5% (95%CI 2.9–8.1), respectively, in the surgically resected versus unresected cohort post NACT (P < 0.0001). Grade 3 or above adverse events were seen in 97 (39.1%) and 179 (72.5%) patients in the TP and TPF arms, respectively (P < 0.0001). NACT with TPF has a survival benefit over TP in borderline resectable oral cancers, with an increase in toxicity which is manageable. Patients who undergo surgery achieve a relatively good, sustained survival. •Phase 3 study in borderline resectable locally advanced oral cancer.•495 patients were randomized 1:1 to cisplatin + 5FU (TP) + /- docetaxel (TPF).•5-year OS in TP was 18.5% and TPF= 23.9%; P = 0.015.•Patients undergoing surgery had a 5-year OS of 50.7%, vs. 5% in those who did not.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0959-8049 1879-0852
DOI:	10.1016/j.ejca.2024.113560