Neal Ready

18502 Background: Achieving a pathologic complete response (pCR) to neoadjuvant chemotherapy is associated with improved survival in a number of solid tumors. SWOG 9900 demonstrated a 3% pCR rate following 3 cycles of q3week paclitaxel and carboplatin in resectable NSCLC. The BrUOG sought to determine if substituting more dose-intense weekly paclitaxel would increase the pCR rate. METHODS: Biopsy proven, consenting patients (pts) with stage IB-IIIA NSCLC and an adequate estimated post-resection FEV1 were eligible. Mediastinoscopy was performed on all patients prior to enrollment into the study. Patients received carboplatin AUC 6 q3weeks × 3 and weekly paclitaxel 80mg/m(2) × 9 weeks. RESULTS: Twenty pts with IB (n=17), IIB (n=1) and IIIA (n=2) were enrolled. Fourteen had a performance status (PS) of 0 and six a PS of 1. All pts completed the planned neoadjuvant therapy. Four pts (20%) had grade 4 neutropenia, one developed grade 3 neuropathy and one had grade 3 nausea. One patient refused surgery and received chemoradiation, one patient died unexpectedly of a non-treatment-related event, and surgery is pending for one patient. The other 17 patients underwent complete resection, either lobectomy (14) or pneumonectomy (3). There were no significant post-surgical complications. By intent to treat, the pCR rate was 16% (3/19); 5 additional pts (26%) had a radiographic partial response, but residual viable disease at surgery. No patient progressed during induction treatment. At median follow-up of 28 months the median survival has not been reached. Four pts have recurred; however, all pts who achieved a pCR with induction chemotherapy remain free of disease. CONCLUSIONS: Neoadjuvant weekly paclitaxel with q3week carboplatin is well tolerated in resectable NSCLC, with a pCR rate that compares favorably to other reported induction regimens and merits further investigation. No significant financial relationships to disclose.

OBJECTIVES: There are limited real-world data about patient-reported outcomes with immunotherapies (IO) in metastatic non-small cell lung cancer (mNSCLC). We describe patient-reported distress and clinical outcomes with IO-based treatments or cytotoxic chemotherapies (Chemo). METHODS: We conducted a single-institution retrospective chart review of adults with mNSCLC treated at Duke from 03/2015 to 06/2020. At each visit, patients self-reported their distress level and sources of distress using the NCCN Distress Thermometer (DT) and its 39-item Problem List. We abstracted demographic, clinical, distress, and investigator assessed-clinical response data, then analyzed these using descriptive statistics and generalized estimating equations. RESULTS: Data from 152 patients were analyzed in four groups: Chemo alone, IO + Chemo, single agent IO, dual agent IO. Distress was worse before treatment start in all groups, and the odds of actionable distress (DT score > 4) decreased by 10 % per month. The most frequent sources of distress were physical symptoms (e.g., fatigue, pain), which remained high longitudinally. Patients receiving IO had higher clinical response rates and a lower rate of unplanned healthcare encounters compared to patients treated with Chemo alone. Only one-third of all patients were seen by palliative care. CONCLUSIONS: This single-center, real-world evidence study demonstrates that patients with mNSCLC experience significant distress prior to starting first-line treatment. IO treatment was associated with higher clinical benefit rates and lower healthcare utilization compared to chemotherapy. Symptom distress persists over time, highlighting potential unmet palliative and supportive care needs in mNSCLC care in the IO treatment era.

BACKGROUND: The availability of new immuno-oncology therapeutics markedly impacts oncology clinicians' treatment decision-making. To effectively support healthcare professionals (HCPs) in their practice, it is important to better understand the challenges and barriers that can accompany the introduction of these agents. This study aimed to establish the types and causes of clinical challenges posed by the introduction of new immuno-oncology agents. METHODS: The mixed-methods design included qualitative in-depth interviews and group discussions with HCPs, in which participants discussed clinical challenges and potential underlying reasons for these challenges. Qualitative findings informed a quantitative survey. This survey investigated the extent and distribution of challenges using HCPs' self-rating of knowledge, skill, confidence, and exposure to system-level effects. These two phases were conducted sequentially with distinctly stratified samples of oncologists, nurse practitioners (NPs), physician assistants (PAs), pathologists, clinical pharmacists, interventional radiologists, rheumatologists, pulmonologists, and emergency department physicians. Participants were from the United States and had various levels of clinical experience and represented both academic and community-based settings. RESULTS: The final sample included 107 HCPs in the qualitative phase and 554 in the quantitative phase. Analyses revealed clinical challenges related to the use of pharmacodiagnostics. For example, 47% of pathologists and 42% of oncologists reported skill gaps in identifying the appropriate marker and 46% of oncologists, 61% of PAs, 66% of NPs, 74% of pulmonologists and 81% of clinical pharmacists reported skill gaps in selecting treatment based on test results. Challenges also emerged regarding the integration of immuno-oncology agents, as oncologists, rheumatologists, pulmonologists, clinical pharmacists, PAs, and NPs reported knowledge gaps (74-81%) of the safety profiles of recently approved agents. In addition, 90% of clinical pharmacists reported skill gaps weighing the risks and benefits of treating patients with immuno-oncology agents while affected by lupus. Finally, patient communication challenges were identified: HCPs reported difficulties discussing essential aspects of immunotherapy to patients as well as how they might compare to other types of therapies. CONCLUSION: The challenges highlighted in this study reveal substantial educational gaps related to the integration of immuno-oncology agents into practice for various groups of HCPs. These findings provide a strong base of evidence for future educational initiatives.