Dose modifications were performed according to the study protocol. The next treatment cycle was initiated only when the neutrophil count was 1.5 × 109/L or greater and the platelet count was 100 × 109/L or greater. Treatment was delayed in the event of grade 3/4 nonhematologic toxicities until the toxicities were resolved to grade 1 or lower. The doses of gemcitabine and S-1 were reduced by 25% of the initial doses for related grade 3/4 neutropenia, grade 3 febrile neutropenia, grade 3 thrombocytopenia, or for the second occurrence of the same grade 2 neutropenia and thrombocytopenia. The doses of gemcitabine were reduced by 50% of the initial doses for grade 4 thrombocytopenia, or for the second occurrence of the grade 3/4 neutropenia, grade 3 febrile neutropenia, grade 3 thrombocytopenia, or for the third occurrence of grade 3 neutropenia and thrombocytopenia. In the case of the second occurrence of grade 2 thrombocytopenia, grade 3/4 neutropenia, grade 3 febrile neutropenia, or the third occurrence of grade 2 neutropenia, erlotinib was omitted until recovery and then re-challenged. Treatment was discontinued if, despite the dose reduction, the same toxicity occurred for a fourth time at grade 2, a third time at grade 3, or a second time at grade 4 or any occurrence of life-threatening sepsis during treatment. In addition, if the toxicity had not improved to grade 0 or 1 after 3 weeks, the patient was withdrawn from the study. The dose reduction was maintained in subsequent cycles.

To evaluate a function of the drug and the frequency of administration, we calculated the relative dose intensity (RDI), which is expressed as the ratio of the administered amount of dose per time unit (mg/m2/week) to that of the originally planned dose.

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