Medknow Publications on behalf of Indian Cancer Society
Abstract
Oropharynx is an important site of cancer in India. Global comparison
indicates higher incidences in India. Radiotherapy remains an important
treatment modality. Efforts to improve loco-regional treatment and
prolong survival are areas of focus. Radiosensitizers in hypoxic tumors
have shown promise. Aim: To study the safety and radiosensitizing
efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage
T2-4, N0-3, M0) as phase-II double blind controlled trial in patients
treated with conventional radiotherapy. SETTINGS AND DESIGN: Single
institutional, randomized, double-blind, placebo-controlled trial.
MATERIALS AND METHODS: Group 1 (control; n =23) received normal saline
infusion, group 2 (test; n =23) received sanazole biweekly 1.25 g
intravenous infusion 15 minutes before radiotherapy. Surrogate end
points of efficacy were tumor and nodal size; safety parameters were
mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia
and neurological deficit. Investigators blinded to the trial evaluated
patients, weekly during treatment for six weeks and thereafter monthly
for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi
square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients
had complete response, five (22%) partial/no response, two (9%) died,
one (4%) lost to follow up. In the control, five (22%) patients had
complete response, 16 (70%) partial/no response, one (4%) died, one
(4%) lost to follow up. Short-term loco-regional response was better in
the test ( DF = 3 , 95% Confidence Interval 0.418, 0.452, P=0.0048 ).
In the test group significant vomiting and one case of grade 3
neurological deficit was observed. CONCLUSION: The study validates the
usefulness of sanazole for initial loco-regional control in
oropharyngeal cancers