NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma.

Background: A randomized, phase II, placebo-controlled, and blinded clinical trial (NCT01062425) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, versus placebo in combination with radiation and temozolomide in newly diagnosed glioblastoma. Methods: Patients with newly diagnosed glioblastoma were randomly assigned 2:1 to receive (1) cediranib (20 mg) in combination with radiation and temozolomide; (2) placebo in combination with radiation and temozolomide. The primary endpoint was 6-month progression-free survival (PFS) based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted MRI brain scans and was tested using a 1-sided Z test for 2 proportions. Adverse events (AEs) were evaluated per CTCAE version 4. Results: One hundred and fifty-eight patients were randomized, out of which 9 were ineligible and 12 were not evaluable for the primary endpoint, leaving 137 eligible and evaluable. 6-month PFS was 46.6% in the cediranib arm versus 24.5% in the placebo arm (P = .005). There was no significant difference in overall survival between the 2 arms. There was more grade ≥ 3 AEs in the cediranib arm than in the placebo arm (P = .02). Conclusions: This study met its primary endpoint of prolongation of 6-month PFS with cediranib in combination with radiation and temozolomide versus placebo in combination with radiation and temozolomide. There was no difference in overall survival between the 2 arms.

Implementation and Outcomes of a Molecular Tumor Board at Herbert-Herman Cancer Center, Sparrow Hospital.

OBJECTIVE: This paper describes our experience and outcomes from 54 cases presented to the (Molecular tumor board) MTB. METHODS: 54 Cases presented between July 2017 and April 2018 were included in this analysis. These patients had different types of cancers that had either failed standard therapy or were expected to fail and physicians were looking for future options for anticipated progression. Patients who had obvious mutations and were candidates for Targeted Agent and Profiling Utilization Registry or Molecular Analysis for Treatment Choice clinical trials were not included. Oncologists presented the cases virtually and Foundation Medicine scientific and clinical team discussed the molecular pathways to find targeted options or trials. Tumor board attendees included oncologists, nurses, pharmacists, mid-level providers, residents and staff of the Cancer Center. RESULTS: Amongst the 54 cases presented 81% had one or more potentially actionable alteration. 12 (22%) patients received genomically matched therapy as per MTB recommendations. Additional 13 (24%) patients have options available when they progress. Out of 12 patients who got treatment six are alive at the time of this analysis. Genomically matched therapy or Clinical Trials option were offered to the 46% of patients based on the MTB discussion. CONCLUSION: More widespread use of molecular diagnostics, better physician education and multidisciplinary collaboration between the staff involved in diagnosis and treatment, as well as third party payers are necessary for consensus on treatment and care of oncology patients.

Prognostic factors of overall survival for patients with stage II colon cancer.

OBJECTIVE: To analyze factors influencing survival of patients with stage II colon cancer treated at our cancer center (Sparrow Hospital) from February 1996 through December 2006. PATIENTS AND METHODS: Survival analyses on 197 patients' age 71.1±0.9 years (29 to 97) were done using SAS system (V9.3, Cary NC). Analysis included age, gender, stage, surgery type, number of examined lymph nodes, pathological grade, tumor size and the use of adjuvant chemotherapy. RESULTS: Mean follow up length was 48.1±2.3 months (0.1-133) and 56±3.3 (0.2-133) for survivors. The average number of removed lymph nodes was 18±13 (1-103). Adjuvant chemotherapy treatment (5-FU± leucovorin) was given to 49 patients, while others (148) were followed expectantly. There were 90 deaths during follow up. Only age exhibits a statistically significant relationship to survival (Hazard Ratio (HR) =1.06, 95% CI=1.03-1.08, p<0.001). Adjuvant chemotherapy possibly reduced the risk of death by 42% approaching a borderline advantage for survival (HR=0.58, CI=0.33-1.03, p=0.06. The number of removed lymph nodes also showed a possible relationship to survival (HR=0.98, CI= 0.62-1.56, p=0.07). Other investigated factors (gender, type of surgery, etc.) were not significant correlates. CONCLUSION: In this study we found that the most important factor for survival of patients with Stage II colon cancer is the patient's age. Adjuvant chemotherapy showed a borderline significance while the number of resected lymph nodes seemed to be an important survival factor. However, in our study statistical significance was not achieved.