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Swati Kulkarni
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-52 - BR-34- Randomized Trial of Durvalumab & Tremelimumab +/- Platinum Chemotherapy in Patients with Metastatic Squamous or Non-Squamous NSCLC (ID 11791)
16:45 - 18:00 | Presenting Author(s): Swati Kulkarni
- Abstract
Background
Background- Immunotherapy improves survival of patients with non-small cell lung cancer (NSCLC). Current clinical trials are studying various combinations of PD-1/PD-L1 inhibitors and CTLA-4 agents with or without chemotherapy, to enhance treatment efficacy. This trial will determine the effects of adding platinum chemotherapy to combination of check point blockade with durvalumab and tremelimumab in the first line treatment of advanced non-small cell lung cancer.
a9ded1e5ce5d75814730bb4caaf49419 Method
Method- BR-34 is a CCTG led randomized proof-of-concept trial of durvalumab and tremelimumab, with or without platinum-based chemotherapy in patients with metastatic squamous or non-squamous NSCLC. Patients who have histologically confirmed Stage IV NSCLC and wild type EGFR and ALK, PDL-1 unselected, with measurable disease by RECIST 1.1, and available tissue for biomarker testing are eligible and are stratified by stage, histology and smoking status. Primary end point is overall survival. Secondary end points include progression free survival at 1 year, overall response rate, quality of life, cost effectiveness and correlative studies on tissue and blood (including PD-L1, tumour mutation burden and cell-free DNA) with outcomes and response, and PFS by iRECIST (exploratory). In total 300 patients will be recruited from Canada, Australia and Italy. Arm A will receive 4 cycles of fixed doses of tremelimumab (T) 75 mg plus durvalumab (D) 1500 mg every 28 days IV, followed by durvalumab (D) maintenance and Arm B will receive standard platinum-doublet chemotherapy in combination with T+D every 21 days for 4 cycles, followed by maintenance D (with pemetrexed for those with non-squamous histology), until progression.
4c3880bb027f159e801041b1021e88e8 Result
Results- BR-34 was initiated in February 2017 in Canada and total 150 patients have been randomized as of April 2018, including 137 from Canada and 13 from Australia. 28 sites are open to accrual in Canada, 15 in Australia the trial will soon be opened in Italy.
8eea62084ca7e541d918e823422bd82e Conclusion
Conclusion- At the current rate of accrual, the CCTG BR-34 trial should be fully accrued by Q1 2019. This is the first randomized trial of combination checkpoint blockade +/- platinum-doublet chemotherapy in advanced non-small cell lung cancer.
Acknowledgements: BR-34 is an academic, co-operative group trial led by Canadian Cancer Trials Group (CCTG) in collaboration with ALTG and NHMRC Clinical Trials Centre, with support from AstraZeneca and Canadian cancer society. NCT03057106
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P3.CR - Case Reports (Not CME Accredited Session) (ID 984)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.CR-17 - An Interesting Case of Long-Term Immunotherapy Response in Metastatic NSCLC (ID 13504)
12:00 - 13:30 | Presenting Author(s): Swati Kulkarni
- Abstract
Background
Immunotherapy has improved survival in advanced non-small cell lung cancer but optimal duration of treatment is unknown. We present a case of metastatic squamous cell carcinoma of lung, who continued to respond, in spite of short exposure to immunotherapy.
a9ded1e5ce5d75814730bb4caaf49419 Method
A 71 year old male was diagnosed with T2N2M1 squamous cell carcinoma of lung in May, 2012. CT revealed right lung mass 4 cm and left lung lesion 1 cm but no distant metastasis. PET scan revealed FDG-avid lesion in the right lung with SUV of 18.5, sub carinal lymph node and contralaetral nodule with SUV 3.4. His case was reviewed in Lung MCC and the consensus was to treat as stage 4 due to FDG avid contralateral lung nodule.
4c3880bb027f159e801041b1021e88e8 Result
He received 4 cycles of carboplatin and gemcitabine from May to July of 2012, with good response. He had progressive disease in October 2012 and received palliative radiation to the chest. He responded well. Further progression was observed on a PET scan to 7.2 cm hypermetabolic lesion in right lung, right hilar and sub carinal lymph nodes with persistent hypermetabolic activity in the left lung.
Chemotherapy with taxotere was offered form July to October of 2013. CT scan revealed reduction in size of lesion to 5 cm. In July 2014 CT revealed progressive disease with 9.1 cm right lung mass. Standard of care, Erlotinib was offered from August, 2014 to June, 2015 with good response. Further progression was revealed in July,2015 to 9.3 cm with adrenal metastases. Erlotinib was discontinued.
Immunotherapy with Nivolumab was given from September to December of 2015. CT from December,2015 revealed index lesion in the right lung 6.9 cm compared to 9.6 cm. However, the patient developed grade 3 pneumonitis requiring admission to the hospital and was teated with steroids with discontinuation of Nivolumab.The index lesion remained stable on CT in April, 2016. Subsequently he remained stable till progression was observed on CT in May, 2017 to 9.8 cm.
8eea62084ca7e541d918e823422bd82e Conclusion
The immunotherapy has revolutionized the treatment of lung cancer. Nivolumab was offered to this gentleman as a 4th line of treatment. His exposure to immunotherapy was only 3 months, which achieved a durable response of 18 months. Duration of treatment required to achieve durable response might be diffrent for each patient. More studies are needed to find out the optimal exposure to immunotherapy. This might enable a huge cost saving in a publicly funded health system.
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