Amit Dutt Dwary

PURPOSE: We designed this study to evaluate efficacy of modified gemcitabine and oxaliplatin (mGEMOX) over best supportive care (BSC) or fluorouracil (FU) and folinic acid (FA) in unresectable gall bladder cancer (GBC). PATIENTS AND METHODS: Patients with unresectable GBC were enrolled for single center randomized study. Arm A, BSC; arm B, FU 425 mg/m(2) and FA 20 mg/m(2) intravenous (IV) bolus weekly for 30 weeks (FUFA); arm C, gemcitabine 900 mg/m(2) and oxaliplatin 80 mg/m(2) IV infusion on days 1 and 8 every 3 weeks for maximum of six cycles. Eighty-one patients were randomly assigned, arms A (n = 27), B (n = 28), and C (n = 26). RESULTS: Complete response plus partial response in the three groups was 0 (0%), four (14.3%), and eight (30.8%) respectively (P < .001). Two patients in the mGEMOX arm and one patient in the FUFA arm underwent curative resection after chemotherapy. One patient in the mGEMOX arm had complete pathologic response. Median overall survival (OS) was 4.5, 4.6, and 9.5 months for the BSC, FUFA, and mGEMOX arms (P = .039), respectively. Progression-free survival (PFS) was 2.8, 3.5, and 8.5 months for the three groups (P < .001). There was no difference in grade 3/4 toxicities in the chemotherapy arms except transaminitis, which was more prevalent in mGEMOX arm (P = .04). Two patients in the FUFA arm and 10 patients in the mGEMOX arm had grade 3 or 4 myelosuppression. Two patients in the mGEMOX group had neutropenic fever that resolved with antibiotics. CONCLUSION: This randomized controlled trial confirmed the efficacy of chemotherapy (mGEMOX) compared with BSC and FUFA in improving OS and PFS in unresectable GBC.

Temozolomide (TMZ) is an oral alkylating agent with significant activity against glioblastoma multiforme (GBM) and melanoma. It increases survival by 2.5 months when used in combination with radiotherapy as an adjuvant therapy in GBM. Secondary MDS/AML or non-Hodgkin lymphoma attributed to TMZ exposure has been reported. We report a case of non-Hodgkin lymphoma secondary to temozolomide in a 20-year-old female who was treated for GBM with concurrent TMZ and radiotherapy. She developed lymphoma 2 months after completing chemoradiotherapy. Although she was treated with combination chemotherapy for lymphoma, she died of progressive GBM.

4521 Background: GBC is common in females residing in the northern part of India. Surgery is the only curative treatment. Unfortunately most patients present in advance and unresectable stage (median survival 3–4 months). Chemotherapy regimens for GBC are not yet standardized. Studies are few and mostly retrospective with small sample size and usually combine heterogeneous malignancies. Adequately powered RCT are not available. This was rationale to undertake study. Methods: It was single center, open label, three armed RCT. Ethical clearance was taken. Planned sample size was 81 to have type I &amp; type II error probabilities of 0.05 &amp; 0.2 respectively. Primary end point was to compare OS in unresectable GBC between BSC vs. FUFA vs. Gem-Ox arms. Secondary end points were to compare PFS in three arms and toxicity analysis of chemotherapy arms. Inclusion criteria were: proven unresectable GBC, performance state ≤2, adequate bone marrow reserve and normal biochemical profile (bilirubin≤3 mg % &amp; liver enzymes within 5 times of upper limit). Patients in BSC group received symptomatic treatment without anticancer therapy. In FUFA group, weekly bolus doses of 5-FU (425mg/m2) plus Folinic acid (20 mg/m2) were given for a maximum of 30 weeks. In Gem-Ox group patients received gemcitabine (900 mg/m2) plus oxaliplatin (80 mg/m2) days 1 and 8 q3 weekly till maximum of 6 cycles. Results: Eighty one patients were randomized (BSC=27, FUFA=28, Gem-Ox=26). Median OS in BSC, FUFA and gem- Ox arms was 4.5 (CI 0.2–8.8), 5.3 (CI 3–6.2) and 9.3 (CI 5–14) months respectively (p= 0.039)). Median PFS was 2.8 (CI 1.8–3.8), 3.5 (CI 3.2–3.8) and 8.5 (CI 5.7–11.3) months in BSC, FUFA and Gem-Ox arm respectively (p= 0.0001). Chemotherapy arms were generally well tolerated. There was no difference in grade 3/4 toxicities in FUFA and Gem-Ox arm except for deranged liver function test, which was more in Gem-Ox arm (p=0.04). There was no toxic death. Conclusions: Probably this is the first RCT confirming efficacy of chemotherapy (Gem-Ox) compared to BSC in improving OS and PFS in unresectable GBC. Both chemotherapy arms were well tolerated. No significant financial relationships to disclose.

Gastric metastasis from lung cancer is rare. We here present the case of a 59-year-old man with lung adenocarcinoma where isolated gastric metastases were discovered on staging F-FDG PET-CT, confirmed with endoscopy and biopsy.