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Ref Type Journal Article
PMID (26317683)
Authors Takhar HS, Singhal N, Gowda R, Penniment M, Takhar P, Brown MP
Title Phase I study evaluating the safety and efficacy of oral panobinostat in combination with radiotherapy or chemoradiotherapy in patients with inoperable stage III non-small-cell lung cancer.
Journal Anti-cancer drugs
Vol 26
Issue 10
Date 2015 Nov
URL
Abstract Text Panobinostat is a radiosensitizing agent and targets the epigenetics of malignancy. This phase I study evaluated the safety and efficacy of combining oral panobinostat with radiotherapy (RT) or chemoradiotherapy (CRT) in patients with inoperable stage III non-small-cell lung cancer. This study had a parallel dose-escalating design combining oral panobinostat twice a week (dose escalations 20, 30, 45 mg) with either palliative RT (group A) or radical CRT (group B) using a standard chemotherapy protocol of cisplatin and etoposide. In group A (RT), nine recruited patients received treatment with oral panobinostat (doses 20, 30, 45 mg) with RT. Two serious adverse events, rapid atrial fibrillation and tracheo-oesophageal fistula, were not attributable to study treatment. The most common grade 3/4 toxicities were thrombocytopenia and lymphopenia, which resolved promptly after cessation of panobinostat. The disease control rate was 66%, the progression-free survival was 3 months and the median overall survival was 9 months. In group B (CRT), panobinostat dose was not escalated beyond 20 mg because of infection-related complications. Serious adverse events included opportunistic infection associated with treatment-related lymphopenia and febrile neutropenia without a source. One patient had cerebral infarct that was not attributed to study treatment. All patients achieved a partial response to treatment. At 33 months of follow-up, all patients were still alive. Panobinostat can be combined with palliative-dose RT at doses up to 45 mg twice a week with tolerable toxicity. Dose-limiting toxicities prevented the dose escalation of the panobinostat with CRT.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown lung non-small cell carcinoma not applicable Panobinostat + Radiotherapy Phase I Actionable In a Phase I trial, Farydak (panobinostat) in combination with palliative radiotherapy resulted in a disease control rate of 66% (6/9), with a progression-free survival of 3 months and a median overall survival of 9 months in patients with stage III non-small cell lung cancer (PMID: 26317683). 26317683
Unknown unknown lung non-small cell carcinoma not applicable Cisplatin + Etoposide + Panobinostat + Radiotherapy Phase I Actionable In a Phase I trial, Farydak (panobinostat) in combination with chemotherapy (cisplatin and etoposide) and radiotherapy resulted in durable partial response in all (3) treated patients with stage III non-small cell lung cancer (PMID: 26317683). 26317683