RESILIENT (CTRI/2018/02/011808) was a single arm, open label, phase II/III study to test if label agnostic therapy regimens guided by Encyclopedic Tumor Analysis (ETA) can offer meaningful clinical benefit for patients with relapsed refractory metastatic (r/r-m) malignancies. Patients with advanced refractory solid organ malignancies where disease had progressed following ≥2 lines of systemic treatments were enrolled in the trial. Patients received personalized treatment recommendations based on integrational comprehensive analysis of freshly biopsied tumor tissue and blood. The primary end points were Objective Response Rate (ORR), Progression Free Survival (PFS) and Quality of Life (QoL). Objective Response (Complete Response + Partial Response) was observed in 54 of 126 patients evaluable per protocol (ORR = 42.9%; 95% CI: 34.3%–51.4%, p < 0.0001). At study completion, Disease Control (Complete Response + Partial Response + Stable Disease) was observed in 114 out of 126 patients evaluable per protocol (CBR = 90.5%; 95% CI: 83.9% - 95.0%, p < 0.00001) and Disease Progression in 12 patients. Median duration of follow-up was 138 days (range 31 to 379). Median PFS at study termination was 134 days (range 31 to 379). PFS rate at 90 days and 180 days were 93.9% and 82.5% respectively. The study demonstrated that tumors have latent vulnerabilities that can be identified via integrational multi-analyte investigations such as ETA. This approach identified viable treatment options that could yield meaningful clinical benefit in this cohort of patients with advanced refractory cancers.
Sir, Our patient who had concurrent chronic lymphocytic leukemia and hairy cell leukemia, viral serological markers including HIV and hepatitis viruses B and C were tested by the highly sensitive chemiluminescent immunoassay method. With this screening immunoassay, although false positivity can occur, the probability of false negativity is extremely low. This patient tested negative for all the three viruses. He was a previously fit and well gentleman and in light of the above negative tests, we did not think it prudent to further pursue CD4 counts and viral load estimation by polymerase chain reaction. These details could not be incorporated in the original case report due to word limit restrictions. However, the point raised of HIV predisposing to multiple lympho-proliferative malignancies is well taken.
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BRCAm relative to BRCAwt. No statistically significant differences in other EORTC PRO scales were observed. Conclusions: In this study of adult women with HER2-ABC, patients with BRCAm were significantly younger and more likely to have a family history of breast or ovarian cancer than BRCAwt. Patients with BRCAm reported significantly worse role functioning and dyspnea suggesting that BRCAm targeted treatment options leading to PROs improvements in these patients are needed. Legal entity responsible for the study: Pfizer.
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