Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: randomized controlled double blind clinical trial.
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.


OBJECTIVE
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.


METHODS
Single institutional, randomized, double-blind, placebo-controlled trial.


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.


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.


CONCLUSIONS
The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.
Ullal
S D
SD
Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal, India. mpkssu@yahoo.co.in
Shenoy
K K
KK
Pai
M R S M
MR
Chowta
M N
MN
Adiga
S M N
SM
Dinesh
M
M
Kamath
A
A
Kotian
M S
MS
Pai
D K
DK
D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*
D011838:Radiation-Sensitizing Agents; D014230:Triazoles; C072690:AK 2123