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

Vanita Noronha; Vijay Patil; Pankaj Chaturvedi; Vijayalakshmi Mathrudev; Nandini Menon; Atanu Bhattacharjee; Ajay Singh; Zoya Peelay; Shatabdi Chakraborty; Monica Jadhav; Mitali Alone; Priyanka Bhagyavant; Manali Kolkur; Sujay Srinivas; Sudeep Das; Somnath Roy; Tanmoy Mandal; Hollis Dsouza; Saswata Saha; Rahul Rai; Anne Srikanth; Darshit Shah; Arif Khan; Hemanth Muthuluri; Amit Kumar; Amit Agarwal; Anu Rajpurohit; Vasu Babu Goli; Anbarasan Sekar; Anoop Mantri; Aditya Pavan Kumar Kanteti; Swaratika Majumdar; Satvik Khaddar; Ramnath Shenoy; Prahlad Elamarthi; Narmadha Rathnasamy; Lakhan Kashyap; George Abraham; Naveen Booma; Vijay Simha; Devendra Chaukar; Prathamesh Pai; Sudhir Nair; Sarbani Laskar; Kavita Nawale; Priyanka Naidu; Sushmita Salian; Priyanka Shelar; Ravinarayan Raulo; Sachin Babanrao Dhumal; Kumar Prabhash

doi:10.1016/j.ejca.2024.113560

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

Vanita Noronha, Vijay Patil, Pankaj Chaturvedi, Vijayalakshmi Mathrudev, Nandini Menon, Atanu Bhattacharjee, Ajay Singh, Zoya Peelay, Shatabdi Chakraborty, Monica Jadhav, Mitali Alone, Priyanka Bhagyavant, Manali Kolkur, Sujay Srinivas, Sudeep Das, Somnath Roy, Tanmoy Mandal, Hollis Dsouza, Saswata Saha, Rahul RaiAnne Srikanth, Darshit Shah, Arif Khan, Hemanth Muthuluri, Amit Kumar, Amit Agarwal, Anu Rajpurohit, Vasu Babu Goli, Anbarasan Sekar, Anoop Mantri, Aditya Pavan Kumar Kanteti, Swaratika Majumdar, Satvik Khaddar, Ramnath Shenoy, Prahlad Elamarthi, Narmadha Rathnasamy, Lakhan Kashyap, George Abraham, Naveen Booma, Vijay Simha, Devendra Chaukar, Prathamesh Pai, Sudhir Nair, Sarbani Laskar, Kavita Nawale, Priyanka Naidu, Sushmita Salian, Priyanka Shelar, Ravinarayan Raulo, Sachin Babanrao Dhumal, Kumar Prabhash

Population Health and Genomics

Research output: Contribution to journal › Article › peer-review

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Original language	English
Article number	113560
Journal	European Journal of Cancer
Volume	200
Early online date	20 Jan 2024
DOIs	https://doi.org/10.1016/j.ejca.2024.113560
Publication status	Published - Mar 2024

Keywords

Borderline resectable
Head and Neck Cancer
Induction chemotherapy
Neoadjuvant chemotherapy
Oral Cancer
Technically unresectable

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ejca.2024.113560

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Noronha, V., Patil, V., Chaturvedi, P., Mathrudev, V., Menon, N., Bhattacharjee, A., Singh, A., Peelay, Z., Chakraborty, S., Jadhav, M., Alone, M., Bhagyavant, P., Kolkur, M., Srinivas, S., Das, S., Roy, S., Mandal, T., Dsouza, H., Saha, S., ... Prabhash, K. (2024). Phase 3 RCT comparing docetaxel-platinum with docetaxel-platinum-5FU as neoadjuvant chemotherapy in borderline resectable oral cancer. European Journal of Cancer, 200, Article 113560. https://doi.org/10.1016/j.ejca.2024.113560

@article{4ceee3fc63674105a251bb89026b94e1,

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

abstract = "Background: 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. Methods: 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. Results: 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). Conclusion: 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.",

keywords = "Borderline resectable, Head and Neck Cancer, Induction chemotherapy, Neoadjuvant chemotherapy, Oral Cancer, Technically unresectable",

author = "Vanita Noronha and Vijay Patil and Pankaj Chaturvedi and Vijayalakshmi Mathrudev and Nandini Menon and Atanu Bhattacharjee and Ajay Singh and Zoya Peelay and Shatabdi Chakraborty and Monica Jadhav and Mitali Alone and Priyanka Bhagyavant and Manali Kolkur and Sujay Srinivas and Sudeep Das and Somnath Roy and Tanmoy Mandal and Hollis Dsouza and Saswata Saha and Rahul Rai and Anne Srikanth and Darshit Shah and Arif Khan and Hemanth Muthuluri and Amit Kumar and Amit Agarwal and Anu Rajpurohit and Goli, {Vasu Babu} and Anbarasan Sekar and Anoop Mantri and Kanteti, {Aditya Pavan Kumar} and Swaratika Majumdar and Satvik Khaddar and Ramnath Shenoy and Prahlad Elamarthi and Narmadha Rathnasamy and Lakhan Kashyap and George Abraham and Naveen Booma and Vijay Simha and Devendra Chaukar and Prathamesh Pai and Sudhir Nair and Sarbani Laskar and Kavita Nawale and Priyanka Naidu and Sushmita Salian and Priyanka Shelar and Ravinarayan Raulo and Dhumal, {Sachin Babanrao} and Kumar Prabhash",

year = "2024",

month = mar,

doi = "10.1016/j.ejca.2024.113560",

language = "English",

volume = "200",

journal = "European Journal of Cancer",

issn = "0959-8049",

publisher = "Elsevier",

}

Noronha, V, Patil, V, Chaturvedi, P, Mathrudev, V, Menon, N, Bhattacharjee, A, Singh, A, Peelay, Z, Chakraborty, S, Jadhav, M, Alone, M, Bhagyavant, P, Kolkur, M, Srinivas, S, Das, S, Roy, S, Mandal, T, Dsouza, H, Saha, S, Rai, R, Srikanth, A, Shah, D, Khan, A, Muthuluri, H, Kumar, A, Agarwal, A, Rajpurohit, A, Goli, VB, Sekar, A, Mantri, A, Kanteti, APK, Majumdar, S, Khaddar, S, Shenoy, R, Elamarthi, P, Rathnasamy, N, Kashyap, L, Abraham, G, Booma, N, Simha, V, Chaukar, D, Pai, P, Nair, S, Laskar, S, Nawale, K, Naidu, P, Salian, S, Shelar, P, Raulo, R, Dhumal, SB & Prabhash, K 2024, 'Phase 3 RCT comparing docetaxel-platinum with docetaxel-platinum-5FU as neoadjuvant chemotherapy in borderline resectable oral cancer', European Journal of Cancer, vol. 200, 113560. https://doi.org/10.1016/j.ejca.2024.113560

TY - JOUR

T1 - Phase 3 RCT comparing docetaxel-platinum with docetaxel-platinum-5FU as neoadjuvant chemotherapy in borderline resectable oral cancer

AU - Noronha, Vanita

AU - Patil, Vijay

AU - Chaturvedi, Pankaj

AU - Mathrudev, Vijayalakshmi

AU - Menon, Nandini

AU - Bhattacharjee, Atanu

AU - Singh, Ajay

AU - Peelay, Zoya

AU - Chakraborty, Shatabdi

AU - Jadhav, Monica

AU - Alone, Mitali

AU - Bhagyavant, Priyanka

AU - Kolkur, Manali

AU - Srinivas, Sujay

AU - Das, Sudeep

AU - Roy, Somnath

AU - Mandal, Tanmoy

AU - Dsouza, Hollis

AU - Saha, Saswata

AU - Rai, Rahul

AU - Srikanth, Anne

AU - Shah, Darshit

AU - Khan, Arif

AU - Muthuluri, Hemanth

AU - Kumar, Amit

AU - Agarwal, Amit

AU - Rajpurohit, Anu

AU - Goli, Vasu Babu

AU - Sekar, Anbarasan

AU - Mantri, Anoop

AU - Kanteti, Aditya Pavan Kumar

AU - Majumdar, Swaratika

AU - Khaddar, Satvik

AU - Shenoy, Ramnath

AU - Elamarthi, Prahlad

AU - Rathnasamy, Narmadha

AU - Kashyap, Lakhan

AU - Abraham, George

AU - Booma, Naveen

AU - Simha, Vijay

AU - Chaukar, Devendra

AU - Pai, Prathamesh

AU - Nair, Sudhir

AU - Laskar, Sarbani

AU - Nawale, Kavita

AU - Naidu, Priyanka

AU - Salian, Sushmita

AU - Shelar, Priyanka

AU - Raulo, Ravinarayan

AU - Dhumal, Sachin Babanrao

AU - Prabhash, Kumar

PY - 2024/3

Y1 - 2024/3

N2 - Background: 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. Methods: 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. Results: 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). Conclusion: 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.

AB - Background: 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. Methods: 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. Results: 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). Conclusion: 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.

KW - Borderline resectable

KW - Head and Neck Cancer

KW - Induction chemotherapy

KW - Neoadjuvant chemotherapy

KW - Oral Cancer

KW - Technically unresectable

UR - http://www.scopus.com/inward/record.url?scp=85185484530&partnerID=8YFLogxK

U2 - 10.1016/j.ejca.2024.113560

DO - 10.1016/j.ejca.2024.113560

M3 - Article

C2 - 38306841

AN - SCOPUS:85185484530

SN - 0959-8049

VL - 200

JO - European Journal of Cancer

JF - European Journal of Cancer

M1 - 113560

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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