1581P - A randomized phase II trial comparing standard pain control with or without gabapentin for the treatment of pain related to radiation-induced mucosi...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive Care
Head and Neck Cancers
Presenter Tomoko Kataoka
Authors T. Kataoka1, N. Kiyota2, T. Shimada3, M. Toyoda2, Y. Fujiwara2, K. Nibu4, T. Komori5, R. Sasaki6, T. Mukohara2, H. Minami2
  • 1Oral And Maxillofacial Surgery, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 2Medical Oncology And Hematology, Kobe University Hospital, 650-0017 - Kobe/JP
  • 3Department Of Medical Oncology And Haematology, Kobe University Hospital, 650-0017 - Kobe/JP
  • 4Otolaryngology And Head And Neck Surgery, Kobe University Hospital, 650-0017 - Kobe/JP
  • 5Oral And Maxillofacial Surgery, Kobe University Hospital, 650-0017 - Kobe/JP
  • 6Radiation Oncology, Kobe University Hospital, 650-0017 - Kobe/JP

Abstract

Background

Radiation-induced mucositis (RIM) in chemoradiation (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance and outcome. Following retrospective reports that gabapentin might improve RIM-associated pain during CRT, we conducted a randomized phase II trial to analyze the safety and efficacy of gabapentin for RIM-associated pain.

Methods

HNC patients (pts) receiving CRT were randomized to receive standard pain control (SPC) or SPC plus gabapentin (SPC + G). Pts in the SPC arm received acetaminophen and opioids as analgesic, while those in the SPC + G arm received gabapentin in addition to SPC. Gabapentin maintained at dose of 900 mg/day till 4 weeks after CRT. The prescribed RT dose was 66-70 Gy/33-35Fr. Concurrent chemotherapy consisted of a three-week cycle of cisplatin. Primary endpoint was maximum VAS score during CRT. Secondary endpoints were total dose of opioids, change in QOL (EORTC QLQ-C30 and EORTC QLQ-HN 35) from base line to 4 weeks after CRT, and adverse events.

Results

From Apr 2010 to Oct 2011, 22 eligible pts were randomly assigned to receive SPC (n = 11) or SPC + G (n = 11). All pts were Stage III or IV. Twelve were treated in a locally advanced setting and 10 in a postoperative setting. No statistically significant differences were seen in median maximum VAS scores between arms (47 in SPC vs. 74 in SPC + G; p = 0.517). Median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT did not statistically differ but appeared higher in the SPC + G arm (215 mg vs. 745.3 mg; p = 0.880, 1260 mg vs. 1537.5 mg; p = 0.9438). QOL analysis showed significantly worse scores in the SPC + G arm for weight gain (p = 0.005). Adverse events related to gabapentin were manageable. One-year survival rate in both arms was equivalent.

Conclusions

This is the first prospective randomized trial to analyze the safety and efficacy of gabapentin for RIM-associated pain. While survival data was equivalent in both arms, gabapentin may have detrimental effects for RIM and further investigation is warranted.

Disclosure

N. Kiyota: an advisory board member on proper usage of cetuximab for head and neck cancer in Japan (Merck Serono)

All other authors have declared no conflicts of interest.