Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer

Lekha Madhavan Nair; R. Rejnish Kumar; Kainickal Cessal Thomachan; Malu Rafi; Preethi Sara George; K.M. Jagathnath Krishna; Kunnambath Ramadas

doi:10.4103/2278-330X.208840

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ORIGINAL ARTICLE : Head and Neck Cancer

06 (

); 064-068

doi:

10.4103/2278-330X.208840

Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer

Lekha Madhavan Nair¹, R. Rejnish Kumar¹, Kainickal Cessal Thomachan¹, Malu Rafi¹, Preethi Sara George², K.M. Jagathnath Krishna², Kunnambath Ramadas^1,

1 Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala

2 Department of Cancer Epidemiology and Biostatistics, Regional Cancer Centre, Trivandrum, Kerala

*Corresponding author: Prof. Kunnambath Ramadas. ramdasrcc@gmail.com

Published: 2020-12-22

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Abstract

Background: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m²) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. Objectives: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m²) with weekly cisplatin (40 mg/m²) concurrently with radiation in patients with locally advanced head and neck cancer. Patients and Methods: This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m² 3 weekly and Arm B received cisplatin 40 mg/m² weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan–Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment. Results: The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively (P = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively (P = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms. Conclusion: This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in).

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References

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.
Halperin EC, Wazer DE, Perez CA, Brady LW. Principles and Practice of Radiation Oncology. 6th ed. Philadelphia, PA, USA: Wolters Kluwer Lippincott Williams and Wilkins; 2013.
Pignon JP, Bourhis J, Domenge C, Designé L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: Three meta-analyses of updated individual data. Lancet 2000;355:949-55.
Pignon JP, le Maître A, Bourhis J; MACH-NC Collaborative Group. Meta-analyses of chemotherapy in head and neck cancer (MACH-NC): An update. Int J Radiat Oncol Biol Phys 2007;69 2 Suppl: S112-4.
Pignon JP, le Maître A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients. Radiother Oncol 2009;92:4-14.
Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 2003;349:2091-8.
Adelstein DJ, Li Y, Adams GL, Wagner H Jr., Kish JA, Ensley JF, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol 2003;21:92-8.
Bahl M, Siu LL, Pond GR, Kim J, Tannock IF, Bayley A, et al. Tolerability of the intergroup 0099 (INT 0099) regimen in locally advanced nasopharyngeal cancer with a focus on patients' nutritional status. Int J Radiat Oncol Biol Phys 2004;60:1127-36.
de Castro G Jr., Snitcovsky IM, Gebrim EM, Leitão GM, Nadalin W, Ferraz AR, et al. High-dose cisplatin concurrent to conventionally delivered radiotherapy is associated with unacceptable toxicity in unresectable, non-metastatic stage IV head and neck squamous cell carcinoma. Eur Arch Otorhinolaryngol 2007;264:1475-82.
Homma A, Inamura N, Oridate N, Suzuki S, Hatakeyama H, Mizumachi T, et al. Concomitant weekly cisplatin and radiotherapy for head and neck cancer. Jpn J Clin Oncol 2011;41:980-6.
Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, et al. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst 2005;97:536-9.
Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, et al. Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: A prospective randomized trial. J Clin Oncol 2000;18:1458-64.
Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, et al. Concomitant cisplatin significantly improves loco-regional control in advanced head and neck cancers treated with hyperfractionated RT. J Clin Oncol 2004;22:4665-73.
Gupta T, Agarwal JP, Ghosh-Laskar S, Parikh PM, D'Cruz AK, Dinshaw KA. Radical radiotherapy with concurrent weekly cisplatin in loco-regionally advanced squamous cell carcinoma of the head and neck: A single-institution experience. Head Neck Oncol 2009;1:17.
Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: A retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncol 2008;47:1513-8.
Geeta SN, Padmanabhan TK, Samuel J, Pavithran K, Iyer S, Kuriakose MA. Comparison of acute toxicities of two chemotherapy schedules for head and neck cancers. J Cancer Res Ther 2006;2:100-4.
Uygun K, Bilici A, Karagol H, Caloglu M, Cicin I, Aksu G, et al. The comparison of weekly and three-weekly cisplatin chemotherapy concurrent with radiotherapy in patients with previously untreated inoperable non-metastatic squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol 2009;64:601-5.
Kose F, Besen A, Sumbul T, Sezer A, Karadeniz C, Disel U, et al. Weekly cisplatin versus standard three-weekly cisplatin in concurrent chemoradiotherapy of head and neck cancer: The Baskent University experience. Asian Pac J Cancer Prev 2011;12:1185-8.
Espeli V, Zucca E, Ghielmini M, Giannini O, Salatino A, Martucci F, et al. Weekly and 3-weekly cisplatin concurrent with intensity-modulated radiotherapy in locally advanced head and neck squamous cell cancer. Oral Oncol 2012;48:266-71.
Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, et al. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized intergroup study 0099. J Clin Oncol 1998;16:1310-7.
Haselow RE, Warshaw MG, Oken MM, Adams GL, Aughey GL, Cooper JS, et al. Radiation alone versus radiation with weekly low dose cis-platinum in unresectable cancer of the head and neck. In: Fee WE Jr., Goepfert H, Johns ME, Strong EW, Ward PH, editors. Head and Neck Cancer. Toronto, ON: BC Decker; 1990. p. 279-81.
Homma A, Shirato H, Furuta Y, Nishioka T, Oridate N, Tsuchiya K, et al. Randomized phase II trial of concomitant chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin for squamous cell carcinoma of the head and neck. Cancer J 2004;10:326-32.

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[1] Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.

[2] Halperin EC, Wazer DE, Perez CA, Brady LW. Principles and Practice of Radiation Oncology. 6th ed. Philadelphia, PA, USA: Wolters Kluwer Lippincott Williams and Wilkins; 2013.

[3] Pignon JP, Bourhis J, Domenge C, Designé L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: Three meta-analyses of updated individual data. Lancet 2000;355:949-55.

[4] Pignon JP, le Maître A, Bourhis J; MACH-NC Collaborative Group. Meta-analyses of chemotherapy in head and neck cancer (MACH-NC): An update. Int J Radiat Oncol Biol Phys 2007;69 2 Suppl: S112-4.

[5] Pignon JP, le Maître A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients. Radiother Oncol 2009;92:4-14.

[6] Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 2003;349:2091-8.

[7] Adelstein DJ, Li Y, Adams GL, Wagner H Jr., Kish JA, Ensley JF, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol 2003;21:92-8.

[8] Bahl M, Siu LL, Pond GR, Kim J, Tannock IF, Bayley A, et al. Tolerability of the intergroup 0099 (INT 0099) regimen in locally advanced nasopharyngeal cancer with a focus on patients' nutritional status. Int J Radiat Oncol Biol Phys 2004;60:1127-36.

[9] de Castro G Jr., Snitcovsky IM, Gebrim EM, Leitão GM, Nadalin W, Ferraz AR, et al. High-dose cisplatin concurrent to conventionally delivered radiotherapy is associated with unacceptable toxicity in unresectable, non-metastatic stage IV head and neck squamous cell carcinoma. Eur Arch Otorhinolaryngol 2007;264:1475-82.

[10] Homma A, Inamura N, Oridate N, Suzuki S, Hatakeyama H, Mizumachi T, et al. Concomitant weekly cisplatin and radiotherapy for head and neck cancer. Jpn J Clin Oncol 2011;41:980-6.

[11] Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, et al. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst 2005;97:536-9.

[12] Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, et al. Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: A prospective randomized trial. J Clin Oncol 2000;18:1458-64.

[13] Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, et al. Concomitant cisplatin significantly improves loco-regional control in advanced head and neck cancers treated with hyperfractionated RT. J Clin Oncol 2004;22:4665-73.

[14] Gupta T, Agarwal JP, Ghosh-Laskar S, Parikh PM, D'Cruz AK, Dinshaw KA. Radical radiotherapy with concurrent weekly cisplatin in loco-regionally advanced squamous cell carcinoma of the head and neck: A single-institution experience. Head Neck Oncol 2009;1:17.

[15] Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: A retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncol 2008;47:1513-8.

[16] Geeta SN, Padmanabhan TK, Samuel J, Pavithran K, Iyer S, Kuriakose MA. Comparison of acute toxicities of two chemotherapy schedules for head and neck cancers. J Cancer Res Ther 2006;2:100-4.

[17] Uygun K, Bilici A, Karagol H, Caloglu M, Cicin I, Aksu G, et al. The comparison of weekly and three-weekly cisplatin chemotherapy concurrent with radiotherapy in patients with previously untreated inoperable non-metastatic squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol 2009;64:601-5.

[18] Kose F, Besen A, Sumbul T, Sezer A, Karadeniz C, Disel U, et al. Weekly cisplatin versus standard three-weekly cisplatin in concurrent chemoradiotherapy of head and neck cancer: The Baskent University experience. Asian Pac J Cancer Prev 2011;12:1185-8.

[19] Espeli V, Zucca E, Ghielmini M, Giannini O, Salatino A, Martucci F, et al. Weekly and 3-weekly cisplatin concurrent with intensity-modulated radiotherapy in locally advanced head and neck squamous cell cancer. Oral Oncol 2012;48:266-71.

[20] Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, et al. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized intergroup study 0099. J Clin Oncol 1998;16:1310-7.

[21] Haselow RE, Warshaw MG, Oken MM, Adams GL, Aughey GL, Cooper JS, et al. Radiation alone versus radiation with weekly low dose cis-platinum in unresectable cancer of the head and neck. In: Fee WE Jr., Goepfert H, Johns ME, Strong EW, Ward PH, editors. Head and Neck Cancer. Toronto, ON: BC Decker; 1990. p. 279-81.

[22] Homma A, Shirato H, Furuta Y, Nishioka T, Oridate N, Tsuchiya K, et al. Randomized phase II trial of concomitant chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin for squamous cell carcinoma of the head and neck. Cancer J 2004;10:326-32.

Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer

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Abstract

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