{'fraction_non_alphanumeric': 0.048473097430925836, 'fraction_numerical': 0.03829374697043141, 'mean_word_length': 4.403141361256544, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Phase II study of gefitinib and docetaxel as salvage therapy in patients (pts) with advanced pancreatic adenocarcinoma (APC).

4120 Background: There is no standard-of-care second-line chemotherapy for APC. The combination of docetaxel and gefitinib, an inhibitor of epidermal growth factor receptor (EGFR) shows enhanced preclinical activity compared to docetaxel alone. Docetaxel alone has activity in APC, and this phase II trial is designed to evaluate the combination. The primary endpoint is survival with an accrual goal of 45 patients to detect an improvement to 5.25 months (mo) in median survival time by one-sided log-rank test at level α = 0.05.


METHODS
Patients with APC and one prior chemotherapy regimen are eligible for study; EGFR over-expression is not required. Gefitinib is administered at the dose of 250 mg/day orally without interruption. The initial dose of docetaxel was 75 mg/m2 every three weeks (one cycle), but was reduced to 60 mg/m2 due to a high incidence of febrile neutropenia.


RESULTS
31 pts, all with prior gemcitabine therapy, have been enrolled on study to date, with 26 evaluable for toxicity. Patient characteristics: 62% male; 92 % with ECOG performance status 0/1, 8% ECOG of 2; median age 64 years (range 47-82 years). The best response is stable disease (5 pts), median cycles administered 2 (range 1-12). Thus far the median survival time is 4.4 mo, with median time to progression of 2.5 mo. Grade (G) 3/4 febrile neutropenia occurred in 8 out of 18 pts treated at the 75 mg/m2 dose of docetaxel; none has been seen with the 60 mg/m2 dose. Other G 3/4 adverse events include: diarrhea (3.8%), rash (7.7%), constitutional symptoms (11.5%), and nausea (11.5%).


CONCLUSION
The combination of gefitinib and docetaxel at 60 mg/m2 is tolerable, with interim results showing a median survival time of 4.4 mo at this point. If the protocol's goal of median survival time of 5.25 mo is met upon study completion, the combination may be worthy of further investigation. No significant financial relationships to disclose.