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J. Bauml
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-054 - Etirinotecan Pegol (NKTR-102) in the Treatment of Patients with Metastatic NSCLC after Failure of 2nd Line Treatment: A Phase II Study (ID 717)
09:30 - 09:30 | Author(s): J. Bauml
- Abstract
Background:
3rd line treatment options are limited for patient (pts) with metastatic NSCLC. NKTR-102 is a long-acting topoisomerase-I inhibitor designed to concentrate in tumors and provide continuous exposure throughout the chemotherapy cycle. Based on clinical activity of irinotecan in NSCLC, we conducted a Phase II single arm trial to evaluate efficacy of NKTR-102.
Methods:
Pts >18 yrs with histologically proven NSCLC who received 2 prior systemic therapy regimens were eligible. Measurable disease, ECOG PS ≤1 and adequate end organ function were required. NKTR-102, 145mg/m2 was administered IV q3 weeks till progression. Response was assessed q6 weeks by RECIST 1.1. Primary endpoint was overall response rate. Secondary endpoints were progression free survival (PFS), overall survival (OS) and safety. Simon two-stage design was implemented; if 0/12 responses were observed in the 1st stage, the study would be terminated for futility. If there was at least 1 objective response in the 1st stage, the study would continue to stage 2, enrolling an additional 25 pts, for a total of 37.
Results:
Between 01/2013 and 01/2015, 37 pts have been enrolled. Median age 63 yrs (18-82), 45% female, ECOG PS 0=8 pts, 92% current/former smokers, 9 pts with squamous cell, 28 had adenocarcinoma. Median time from diagnosis to initiation of NKTR-102 was 18 mos (6-72). Pts received a median of 3 cycles (1-13). All pts were evaluable for response rate and toxicity. One pt in Stage I (adenocarcinoma) had a partial response. Fifteen pts had stable disease, 7 pts are still on treatment. 3 pts had Grade 3 GI toxicity attributable to NKTR-102. 6 pts required a dose reduction to 120 mg/m2 due to diarrhea. There was no hematological toxicity. Median PFS was 2.3 mos. For pts with >1 yr follow up (n=20), median OS was 5.5 mos. Complete PFS and OS data will be presented.
Conclusion:
NKTR-102 is well tolerated and leads to stabilization of disease in third line treatment of metastatic NSCLC. These clinical data combined with a favorable safety profile warrant further clinical investigation of this agent. Clinical trial information: NCT01773109.
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P3.11 - Poster Session/ Palliative and Supportive Care (ID 231)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.11-012 - Improving Clinical Trial Awareness in NSCLC: Pilot Testing a Novel Healthcare IT Platform for Incorporating Education at the Point of Care (ID 3253)
09:30 - 09:30 | Author(s): J. Bauml
- Abstract
Background:
Cancer clinical trial (CCT) participation is critical to improving the care of patients with Non-Small Cell Lung Cancer (NSCLC), yet low participation in CCTs persists. Little is known about the specific barriers to CCT participation among patients with NSCLC. The On Q Care Planning System (CPS) is an electronic tablet based platform adapted to address potential barriers to CCT participation through algorithm-driven identification of and education about patient specific CCTs at the point of care. The primary objectives of this study were to 1) characterize knowledge, attitudes and beliefs about CCTs among patients with NSCLC and their providers and 2) evaluate the impact of the CPS on CCT participation.
Methods:
We performed a multi-site pilot implementation project of CPS as a clinical decision support and patient education tool. Patients were eligible if they had recurrent/metastatic NSCLC. The CPS contained clinical trial eligibility criteria for many CCTs in NSCLC open at the primary research site, as well as selected CCTs from surrounding cancer centers. Study aims were evaluated using patient and provider self-report surveys. Knowledge, attitudes and beliefs about CCTs for both patient’s and provider’s was captured through self-assessment surveys, using a combination of true/false questions and 1-5 Likert scale measures where 5 indicated highest level of agreement. Effect of CPS on CCT enrollment was measured by rate of enrollment in CCTs following the intervention, compared to historical rates of NSCLC CCT participation at our institution.
Results:
From April 2015 through July 2015, 9 providers (medical oncologists and nurse practitioners) and 79 patients with recurrent/metastatic NSCLC have been enrolled from 2 participating cancer centers. While providers reported being aware of open CCTs (mean score (m)=4.6), they felt that lack of adequate information about CCTs (m=3.0) and having time to review eligibility (m=2.6) were key barriers to CCT enrollment. Patients agreed that there were both the personal (m=3.7) and societal (m=4.1) benefits of CCTs. Similar to providers, key barriers to CCT participation for patients centered around lack of knowledge (concern about not knowing what drug they would receive (m=3.5) and that CCT agents would be too toxic (m=3.2)). Of the patients enrolled, 22 were at a point of new treatment or change in treatment and thus evaluable for rate of CCT referral and enrollment. In this subgroup, 21 (95.5%) received care plans with CCT recommendations. Following the study intervention visit, 8 (36.4%) of evaluable patients enrolled in a clinical trial. This compares favorably both with historical rates at our institution, where 13.8% of treatment eligible patients with lung cancer have been enrolled in CCTs, and with national averages which are less than 5%.
Conclusion:
CCT enrollment is critical to advancing the treatment of NSCLC, yet CCT enrollment in NSCLC remains low. For both providers and patients, the lack of readily accessible information about clinical trial eligibility and protocol details is a major barrier to CCT enrollment. The CPS is specifically designed to address these barriers. Indeed, in this pilot study, we showed a promising rate of CCT accrual with the use of the CPS. These findings should be validated in larger, randomized studies.
