Randomized Neoadjuvant Trials

First Author, Year

N

Drugs

Response Rate (%)

Survival Benefit

Taylor,42 1 98 5

82

Methotrexate

40

NS*

Toohill,36 1987

60

Cisplatin 5-fluorouracil

85

NS

HNCP,t40 1 98 7

443

Cisplatin Bleomycin

37

NS

Schuller,43 1988

158

Cisplatin Methotrexate Bleomycin Vincristine

70

NS

DVALCSG,*16 1991

332

Cisplatin 5-fluorouracil

85

NS

Dalley,44 1995

280

Cisplatin 5-fluorouracil

80

NS

Lefebvre,37 1996

194

Cisplatin 5-fluorouracil

86

NS

Lewin,15 1997

461

Cisplatin 5-fluorouracil

71

NS

Salvajoli,45 1997

60

Vinblastine Mitomycin-C Cisplatin Bleomycin

60

NS

*Not significant t Head and Neck Contracts Program

^The Department of Veterans Affairs Laryngeal Cancer Study Group

*Not significant t Head and Neck Contracts Program

^The Department of Veterans Affairs Laryngeal Cancer Study Group response or salvage after radiation (as compared to 38% in the VALCS trial). The EORTC trial also showed that 28% of patients could be expected to be alive with a functioning larynx at 3 years. No difference was found in overall survival.

These reports and others, including the noncontrolled trial from M.D. Anderson, show that induction chemotherapy can be used to retain a functioning larynx without compromising survival.13 A major question raised from these studies is whether the neoadjuvant chemotherapy is really any benefit or is simply a selection marker for those who will respond to radiation. To help answer this question, the Head and Neck Intergroup is conducting a study that will accrue 546 patients divided into three groups: (1) induction chemotherapy (similar to the VALCS protocol) followed by radiotherapy for responders, and salvage surgery with postoperative radiation for nonresponders; (2) radiotherapy with concomitant chemotherapy (cisplatin alone); and (3) radiotherapy alone.46 The goal of this study is to determine the true benefit of induction chemotherapy over radiotherapy alone for organ preservation, as well as to evaluate the efficacy of concomitant chemo- and radiotherapy. There is still the question of selecting out the responders to radiation. Laboratory tests may be able to make this prediction independent of having the patient undergo the toxicity of chemother apy. Bradford et al.47 looked at the p53 status of 178 of the tumors from the VALCS study and found a significant correlation with overexpression of p53 and response to radiotherapy, but no correlation with overall survival. Neoadjuvant chemotherapy for advanced, previously untreated, laryngeal cancers is generally the accepted regimen.

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