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P. Wheatley-Price
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MA 10 - Immunotherapy I (ID 664)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:S. Wang, Robert Pirker
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 303 + 304
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MA 10.01 - Durvalumab ± Tremelimumab with Platinum-Doublets in Non-Small Cell Lung Cancer: Canadian Cancer Trials Group Study IND.226 (ID 8700)
11:00 - 11:05 | Author(s): P. Wheatley-Price
- Abstract
- Presentation
Background:
Anti-PD1-monotherapy has activity in NSCLC with improved outcomes compared to chemotherapy. Preclinical, and early clinical data, suggests that combining immune checkpoint inhibitors and platinum-based chemotherapy may be synergistic. We examined the cohort of patients (pts) with metastatic NSCLC, with no prior therapy for advanced disease, from this multicentre phase Ib trial. The primary objective was to establish the recommend phase II doses of durvalumab (Du) ± tremelimumab (Tr) in combination with platinum-doublet chemotherapy. Secondary objectives included assessing safety, tolerability, and antitumour activity of the 4-drug combination.
Method:
Pts were treated with Du±Tr at one of 4 dose levels (DL) concomitantly with either pemetrexed (Pem) +cisplatin/carboplatin followed by maintenance Pem for nonsquamous histology or gemcitabine (Gem) +cisplatin/carboplatin for squamous tumours. At DL0 Du 15 mg/kg IV q3wks was added; DL1 added Du 15mg/kg q3wk + Tr 1mg/kg x1 dose; DL2a added Du 15mg/kg q3wk + Tr 1 mg/kg q6wk x multiple doses; DL2b added Du 15mg/kg q3wk + Tr 3 mg/kg q6wk (1 dose with cycle 1 and 2 doses with maintenance pem), DL3 and DL4 added a fixed doses of Du 1125mg/Tr 56 mg and Du 1500 mg/ Tr 75 mg q3wk respectively. Du could continue until 1 year or unacceptable toxicity.
Result:
To date, 45 pts (median age=62 (range 36-78); 44% male, 100% ECOG PS≤1) have received 346 cycles in the Pem-platinum cohort while 9 pts (median age=64 (range 57-80); 78% male, 100% ECOG PS≤1) have been received 55 cycles in the Gem-platinum group. Most adverse events were ≤grade 2 and attributed to chemotherapy. Immunotherapy-related adverse events (irAEs) ≥ grade 3 were observed in 27% of patients and were more commonly reported with the addition of Tr. In the Pem-platinum cohort, diarrhea (n=5), fatigue (n=4) and elevated lipase (n=4) were the most come irAEs ≥ grade 3, while rash, pneumonitis and hypothyroidism occurred in 1 pt each after the introduction of Tr. In the Gem-platinum cohort, irAEs ≥ grade 3 were fatigue and rash (1 pt each at DL2b) and elevated lipase (1 pt at DL3). The objective response rate in 35 evaluable patients receiving Pem-platinum was 57.1% (95% CI=39.4, 73.7 ) and 37.5% (95% CI=8.5, 75.5) in the 8 evaluable patients receiving Gem-Platinum.
Conclusion:
The combination of Du±Tr can be safely administered with platinum-doublet chemotherapy with encouraging preliminary response data. Adding Tr may increase ≥ grade 3 irAE hence patient selection and early intervention is key to managing irAEs. *contributed equally
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OA 11 - Reducing Burden: Patient-Centered Care (ID 682)
- Event: WCLC 2017
- Type: Oral
- Track: Nursing/Palliative Care/Ethics
- Presentations: 1
- Moderators:Beth Ivimey, E. Bernicker
- Coordinates: 10/18/2017, 11:00 - 12:30, Room 313 + 314
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OA 11.06 - Lung Cancer Diagnosis and Assessment as a System Design Problem: Creating an Award Winning Program with Patient Advocates as Co-Designers (ID 10203)
11:55 - 12:05 | Author(s): P. Wheatley-Price
- Abstract
- Presentation
Background:
Lung cancer continues to have a high mortality in Canada, with many patients presenting with advanced stage disease. The Ottawa Hospital (TOH) used a learning health systems (LHS) approach to redesign regional diagnostic processes to reduce the overall time from presentation with a suspicious lung mass to diagnosis and treatment. As previously published by our group, an LHS approach is driven by feedback utilizing operational and clinical information to drive system optimization and innovation. TOH is the only provider of cancer services for a population of 1.3 million people in eastern Ontario and hence the need for an integrated patient journey from regional health facility to tertiary care centre was identified. Patient advocates have been incorporated as key members of the LHS from inception to implementation to post-implementation review.
Method:
The Ottawa Health Transformation model (OHTM) was developed as a means of operationalizing a LHS. A kick off meeting brought together cancer patients and their families to map out existing processes and document the patient experience. A regional lung cancer Community of Practice (CoP) of clinical and non-clinical stakeholders was then established to guide and approve the work of a core transformation team. The team had patient and family advocates as key members and they were tasked with identifying appropriate wait time targets and vetting proposed processes. A consensus approach was used to address process barriers, resistance to change and conflicting priorities in regular meetings spanning over two years. Commercially available software was used to track patient progress through the diagnostic process and to report real time metrics to the transformation team.
Result:
The project operationalized lung cancer diagnostic pathway guidance and optimized patient flow from referral to initiation of treatment. Twelve major processes in referral, review, diagnostics, assessment, triage and consult were redesigned. TOH now provides a diagnosis to 80% of referrals within the provincial target of 28 days and leads all other jurisdictions in Ontario in this metric by a wide margin. The median patient journey from referral to initial treatment decreased 48% from 92 to 47 days. In 2016 this work was recognized by a provincial cancer agency with a quality award.
Conclusion:
A learning health system has significantly reduced the time from referral with suspicion of lung cancer to diagnosis to treatment. Achievements require a multi-disciplinary approach with a regional perspective. Patient and family advocates have an important voice in re-designing health care systems.
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-032 - A Randomized Phase Ii Trial of Selumetinib + Platinum-pemetrexed (Pem-c) in Kras Wildtype (Wt)/Unknown NSCLC: CCTG Ind219 (ID 9083)
09:00 - 09:00 | Author(s): P. Wheatley-Price
- Abstract
Background:
Selumetinib (SEL), an oral inhibitor of MEK 1 and 2, could be particularly effective in tumours with an activated Ras/Raf/MEK/ERK pathway, but has not been fully studied in KRAS WT nor in the first-line setting. The scheduling of SEL with chemotherapy might impact efficacy and/or toxicity.
Method:
IND219 is an open-label three-arm study of PEM-C±SEL. Arm A: PEM-C+SEL days 2-19; Arm B: PEM-C+SEL days 1-21; Arm C: PEM-C alone. Primary objective was response rate (ORR); secondary objectives were tolerability and progression-free survival (PFS). Pts were stratified by KRAS WT versus unknown and cisplatin versus carboplatin. Before the planned interim analysis (60 pts), pts were allocated 1:1:1 to arm A, B or C, with a plan to continue either Arm A or B plus Arm C a 3:1 ratio to ensure that the final analysis includes Arm A or B and Arm C in a 2:1 ratio. The trial would stop if neither Arm A or B had > 4 responses; if both did, the arm would be selected based on response and toxicity data. Correlative studies included genomic testing.
Result:
Arm A/B/C enrolled 20/21/21 pts. PEM-C exposure was lower with SEL (median cycles 5 versus 6 for Arm C). Seven pts on Arm A (35%; 95% CI 15-59% median duration 3.8m), 13 on Arm B (62%; 95% CI 38-82%; median duration 6.3m), and 5 on Arm C (24%; 95% CI 8-47%; median duration 11.6m) had PR, meeting the criteria to continue. PFS was 7.5m (95% CI 4.0 to 9.0 m) for Arm A, 6.7m (95% CI 4.1 to 8.2 m) on Arm B, and 4.0m on Arm C (95% CI 1.4 to 6.8 m). HR for PFS of Arm A over Arm C was 0.76 (95% CI 0.38 to 1.51, 2-sided p=0.42); HR for PFS of Arm B over Arm C was 0.75 (95% CI 0.37 to 1.54, p=0.43). After adjusting for age, performance status, gender and KRAS, PFS comparisons remained NS. Toxicity was most commonly grade 1-2, but more frequent with SEL especially mucositis, diarrhea, anorexia, dehydration, edema and rash. A high rate of venous thromboembolism (VTE) was seen in all arms, highest in Arm A (Arm A 45 % versus 14 % [p=0.11])
Conclusion:
SEL+PEM-C is associated with higher, but less durable ORR. In this small study, PFS is numerically prolonged adding SEL to PEM-C with expected additive toxicity. Further exploration of these intriguing results is ongoing.
