Study treatment and efficacy
toxicity, amputation, tumor
DISEASE PROGRESSION, TUMOR, ORAL MUCOSITIS
Gemcitabine at median dose of 1400 mg (range 1000–1700 mg) and docetaxel at median dose of 120 mg (range 90–140 mg) were administered for a median of 4 cycles (range 2–4) during the study period of 12 weeks. Overall, the median number of cycles received for the entire course of treatment was 4 cycles (range 2–6). Reduction of the starting dose was required in 4 (18.1%) patients due to amputation in 3 (13.6%) and prior exposure to spinal radiotherapy in 1 (4.5%) patient. 3 (13.6%) patients required dose reductions during the therapy, at median 25% (range 25–50%) with the most common indication being grade 3 oral mucositis (2, 9%). The median starting intensity of chemotherapy was 100% (range 75–100) and the lowest dose received was 50% in 1 patient. 7 (31.8%) patients experienced delays in their chemotherapy schedule for a median of 7 days (range 4–17 days), most frequently due to hematological toxicity. The 3-month PFR was 45.4% (95% CI 24.8–66.1%) with 10 patients free of progression at the end of the study period. Of these, 9 patients (41%) attained SD and 1 patient (4.5%) had PR to the treatment at 12 weeks (Fig. Waterfall plot representing the percentage maximum tumor reduction at 12 weeks of treatment according to RECIST version 1.1. [Patients who had disease progression based on development of new lesions without increase in dimensions are labelled with “ + ”]Kaplan–Meier analyses of (Multiple patients received more than 1 line of therapy after completion of the study period including 7 (31.8%) who completed total 6 cycles of GD. The other treatments administered after the study were pazopanib (10, 45.4%), regorafenib (5, 22.7%), ifosfamide (3, 13.6%), temozolomide (2, 9%) and anlotinib (2, 9%). 1 patient (4.5%) underwent enrolment in a phase I/II clinical trial of epigenetic modifier-based therapy.