Prevention of second primary tumors with isotretinoin in squamous-cell carcinoma of the head and neck.
BACKGROUND
Patients with head-and-neck cancers who are free of disease after local therapy remain at high risk for both recurrent and second primary tumors. Retinoids have proved efficacious in the treatment of premalignant oral lesions and are promising agents for the prevention of epithelial carcinogenesis.


METHODS
We prospectively studied 103 patients who were disease-free after primary treatment for squamous-cell cancers of the larynx, pharynx, or oral cavity. After completion of surgery or radiotherapy (or both), these patients were randomly assigned to receive either isotretinoin (13-cis-retinoic acid) (50 to 100 mg per square meter of body-surface area per day) or placebo, to be taken daily for 12 months.


RESULTS
There were no significant differences between the two groups in the number of local, regional, or distant recurrences of the primary cancers. However, the isotretinoin group had significantly fewer second primary tumors. After a median follow-up of 32 months, only 2 patients (4 percent) in the isotretinoin group had second primary tumors, as compared with 12 (24 percent) in the placebo group (P = 0.005). Multiple second primary tumors occurred in four patients, all of whom were in the placebo group. Of the 14 second cancers, 13 (93 percent) occurred in the head and neck, esophagus, or lung.


CONCLUSIONS
Daily treatment with high doses of isotretinoin is effective in preventing second primary tumors in patients who have been treated for squamous-cell carcinoma of the head and neck, although it does not prevent recurrences of the original tumor.
Department of Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030.
W K
WK
Hong
S M
SM
Lippman
L M
LM
Itri
D D
DD
Karp
J S
JS
Lee
R M
RM
Byers
S P
SP
Schantz
A M
AM
Kramer
R
R
Lotan
L J
LJ
Peters
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D015474:Isotretinoin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009378:Neoplasms, Multiple Primary / Q000517:prevention & control*; D010349:Patient Compliance; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012907:Smoking / Q000009:adverse effects
D015474:Isotretinoin