A randomized phase II trial conducted by the
Cancer and
Leukemia Group B in patients with unresectable
non-small cell lung cancer showed that
induction chemotherapy followed by concurrent
radiotherapy and
chemotherapy was feasible when
cisplatin was administered together with either
gemcitabine,
vinorelbine, or
paclitaxel. The dominant toxicity was
esophagitis. Preliminary survival data are encouraging. Other trials in progress or planned will elucidate the relative contributions of induction and concurrent
therapy to outcome. A phase I study has shown that it is feasible to combine
docetaxel (
Taxotere: Aventis, Antony, France) with concomitant
radiotherapy in patients with advanced non-small cell lung or
esophageal cancer. Giving the
drug once every 3 weeks during standard
radiotherapy, the maximum tolerated dose is 40 mg/m2 per cycle. The dose-limiting toxicities are
neutropenia and
esophagitis. However, it is possible to escalate the total
docetaxel dose to 60 mg/m2 per cycle by weekly administration of 20 mg/m2. Beyond this point,
esophagitis is dose limiting. In the palliative-intent treatment setting, the weekly administration of
docetaxel is also likely to be a helpful new approach to administering the
drug in subgroups of patients such as the elderly and those with concomitant disease. Weekly
docetaxel (36 mg/m2/wk) was administered to patients with advanced
non-small cell lung cancer who were elderly (median age, 71 years) or had poor performance status. In this unfavorable group, weekly
docetaxel produced
a 19% objective response rate and with further follow-up, 1-year survival is 28%. This level of activity is similar to other single agents recently evaluated in more favorable patient groups. The lack of myelosuppression seen with weekly administration suggests that the dose intensity of
docetaxel could be maintained in combination regimens.