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S. Ahmed
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-015 - STOMP: A UK National Cancer Research Network Randomised, Double Blind, Multicentre Phase II Trial of Olaparib as Maintenance Therapy in SCLC (ID 4269)
14:30 - 14:30 | Author(s): S. Ahmed
- Abstract
Background:
STOMP (ISRCTN 73164486, CRUK/10/037, EudraCT 2010-021165-76) is a randomised, double-blind, placebo-controlled phase II trial to evaluate activity and safety of the PARP inhibitor olaparib (AstraZeneca) as maintenance treatment for patients with chemo-responsive small cell lung cancer (SCLC). Two schedules of olaparib oral tablets were investigated: 300mg twice daily (bd) or 200mg three times daily (tds).
Methods:
Eligible patients had pathologically confirmed SCLC with response to first line chemotherapy or chemo-radiotherapy. Patients were stratified by metastasis-status and prior radiotherapy and randomised in a 2:2:1:1 ratio to: olaparib tds, olaparib bd, placebo tds or placebo bd. Placebo arms were pooled for analyses. Primary outcome was progression-free survival (PFS). There is 80% power to detect a difference of 3 months in PFS (from 4.8 months) between treatments based on a one-sided 5% significance level. Key secondary outcome measures were overall survival (OS), adverse events (AEs) and quality of life.
Results:
Between November 2013 and December 2015, 220 UK patients were randomised. Arms were well balanced for stratification factors of prior radiotherapy (89% Yes) and metastasis status (66% M1) as well as sex (46% M) and age (median=64, range 42-89). Median follow-up for 31 event-free patients was 14 months (range 0–24). Median PFS was 2.6 (90%CI 1.8, 3.7), 3.6 (90%CI 3.1, 6.0) and 3.6 (90%CI 3.1, 4.7) months in the placebo, olaparib bd and tds arms, respectively. There was no significant difference in PFS between olaparib and placebo for either the bd (Cox-Adjusted HR 0.87; 90% CI 0.64, 1.18; stratified logrank p=0.29) or the tds arm (0.89; 90% CI 0.67, 1.20; p=0.43). Median OS was 8.9 (90%CI 7.0, 11.9), 9.9 (90%CI 7.6, 12.9) and 9.0 (90%CI 6.6, 11.8) months in the placebo, olaparib bd and tds arms, respectively. There was no significant difference in OS between olaparib and placebo for either the bd (Cox-Adjusted HR 0.97; 90% CI 0.69, 1.37; stratified logrank p=0.73) or the tds arm (1.05; 90% CI 0.76, 1.46; p=0.73). The most common AEs on olaparib were fatigue, nausea, anaemia, vomiting and anorexia. 68 patients discontinued treatment citing AEs (17 placebo, 26 olaparib bd, 25 olaparib tds).
Conclusion:
There is no evidence that either the bd or tds regimen for olaparib improves PFS or OS in an unselected population. The AE profile for olaparib in SCLC is similar to that observed in other studies.
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-019 - Lung Cancer in Young Adults (Age Group 18-50 yrs): Presentation, Clinical Features and Treatment (ID 5755)
14:30 - 14:30 | Author(s): S. Ahmed
- Abstract
Background:
Background-Non small cell lung cancer in young adults appears to be increasing over recent years. It’s a devastating illness both for the patient and their family. It has got significant socioeconomic implications.
Methods:
Methods-Data were analysed for the period between 2010-2015 from the University Hospitals of Leicester data base. Young adults were defined as age less than 50 and further sub divided into 18-39 years and 40-50 years of age respectively. Data were extracted regarding the histological diagnosis of cancer, performance status, disease staging and the treatment received.
Results:
Results-From a total of 93 patient’s we found the majority had adenocarcinoma,with 56% in the 18-39 age group and 63.6% in 40-50 age group. A greater proportion of patients in each age group were found to have a performance status of 0.The number of male patients were noted to be slightly higher between 18-39 (55%), compared to the 40-50 age groups, where there was a female predominance (57%). The majority of patients in both age groups were found to have a good performance status and a larger proportion of patient’s eGFR status was negative. Young adults were more likely to have surgery and chemotherapy due to their better performance status.
Conclusion:
Conclusion: In our cohort of young adults with lung cancer, the majority of patients had a good performance status despite late stage disease.They were likely to be fit for treatment and have longer survival outcomes.
