Given the limited therapeutic armamentarium for STS, the activity of gemcitabine is encouraging. Its potential for combination therapy in the salvage setting should be studied with pharmacologically guided fixed dose-rate infusion.

The authors evaluate the efficacy and feasibility of dose-intensive doxorubicin and ifosfamide combination chemotherapy in patients with sarcomas. From January 1995 to April 1996, 33 evaluable patients with either metastatic sarcoma or primary sarcomas with a high-risk for metastases (all except one was previously untreated with chemotherapy) were treated on two consecutive protocols. The median age was 45 years (range, 15-68 years). The first protocol included doxorubicin at 75 mg/m2 given as a 72-hour infusion on days 1 to 3 along with ifosfamide at 2 g/m2/d over 2 hours x 5, days 1 to 5 (protocol AI 75/10). Granulocyte colony-stimulating factor (G-CSF) was used only if indicated according to American Society of Clinical Oncology guidelines. The second protocol included doxorubicin at 90 mg/m2 as a 72-hour continuous infusion and ifosfamide at 2.5 g/m2/d for 4 days (protocol AI 90/10) with prophylactic G-CSF. A median of four cycles were administered (range, 1-6). Three patients achieved a pathologic complete response (CR) and 18 patients achieved a partial response (PR) for a response rate (RR) of 64% (95% confidence interval (CI), 45-80%). Response rate for the subset of patients with soft-tissue sarcomas was 66% (95% CI, 46-82%). Only three patients progressed on therapy. Febrile neutropenia was noted in 31% of cycles at AI 75/10 and in 56% of cycles at AI 90/10. One patient developed reversible grade 3 central nervous system (CNS) toxicity. There was one treatment-related death on AI 90/10 secondary to doxorubicin cardiac toxicity at a cumulative dose of 435 mg/m2. Dose-intensive doxorubicin plus ifosfamide is feasible in appropriately selected patients and appears to be a very active regimen in patients with sarcomas. The authors are currently testing this regimen with G-CSF and thrombopoietin.

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Objectives: To utilize the RSSearch Patient Registry (RSSPR) to examine local control (LC), overall survival (OS), and toxicities following stereotactic body radiation therapy (SBRT) for stage I (T1-T2/N0) medically inoperable small cell lung carcinoma (SCLC). Materials and Methods: We searched the RSSPR for medically inoperable stage I SCLC patients treated with definitive SBRT. Potential predictive factors of OS were estimated using the Kaplan-Meier method as well as a Cox proportional hazards model. Results: Twenty-one patients were identified with medically inoperable stage I SCLC that met inclusion criteria. Fourteen patients had stage IA SCLC (T1N0) and 7 patients had stage IB SCLC (T2N0) with a median gross tumor volume of 10.1 cm3 (range: 0.72 to 41.4 cm3). The median number of fractions was 4 (range: 3 to 5), and the median BED10 was 105.6 Gy10 (range: 72 to 239.7 Gy10). Four patients received adjuvant chemotherapy. One- and 2-year actuarial OS rates were 73.1% (95% confidence interval [CI]: 36.8%-90.1%) and 36.6% (95% CI: 9.0%-65.7%), respectively. Factors found to be associated with 1-year OS on univariate analysis included T2 disease (85.5% vs. 33.3%; P=0.03), adjuvant chemotherapy (100% vs. 66.3%; P=0.11), and gross tumor volume ≥10 cm3 (100% vs. 52.5%; P=0.10). On multivariate analysis, adjuvant chemotherapy was associated with improved OS (hazard ratio=0.07 [95% CI: 0.13-0.37; P=0.002]). The 1-, 2-, and 3-year LC rates were 100%, and 1- and 2-year progression-free survival (PFS) rates were 85.7% (95% CI: 33.4-97.9%) and 42.9% (95% CI: 1.1-85.3%), respectively. Similar to OS, patients with T1N0 disease had superior PFS as compared to T2N0 disease (P=0.01). Toxicities were reported by 3/21 (14.3%) of patients with none ≥ grade 3 and no esophageal toxicities. Conclusions: SBRT was well-tolerated in the treatment of stage I SCLC with excellent LC achieved. Patients with T1N0 stage IA SCLC were noted to have improved PFS and OS following SBRT as compared with T2N0 Stage IB SCLC. Adjuvant chemotherapy was found to result in improved OS for stage I SCLC patients over SBRT alone.

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