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Sukhmani K. Padda
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MA10 - Assessing and Managing Supportive Care Needs (ID 215)
- Event: WCLC 2020
- Type: Mini Oral
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 1/31/2021, 11:45 - 12:45, Scientific Program Auditorium
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MA10.06 - Healthcare Utilization with an Electronic Patient Reported Outcome (ePRO) tool for Symptom Management in Thoracic Cancers (ID 2020)
11:45 - 12:45 | Author(s): Sukhmani K. Padda
- Abstract
Introduction
Electronic patient Reported Outcomes (ePROs) have been associated with improved symptom management and quality of life in patients with advanced cancer, along with reported decreases in emergency department (ED) use (Basch et al. JCO 2016). However, there are limited follow up studies showing the impact of the implementation of ePROs on healthcare utilization.
Methods
We conducted a randomized clinical trial of an ePRO application compared with standard of care (SOC), in patients with advanced cancer at Stanford Cancer Institute. Here, we report the trends of healthcare utilization in the thoracic cancer subgroup (n=18 in ePRO and n=19 in SOC arms). We assessed baseline demographics, technology use and quality of life. Retrospective chart review assessed points of contact with the thoracic oncology clinic, including telephone and patient portal encounters. We also assessed whether messages and phone calls were related to symptom management, with two reviewers.
Results
37 of 49 patients were assessed, with patients excluded if they did not complete follow up questionnaires. At baseline, 83% of the ePRO patients and 91% of the SOC patients noted using smartphone applications more than once a day. Overall healthcare utilization did not increase with the ePRO, with similar median number of phone calls and electronic patient generated messages (Table 1). We did not note a significant difference between calls or messages related to symptoms as well.
Pre-During-and Post-Trial Healthcare Utilization
(Median (Interquartile Range))
Phone Encounters
6 months prior to trial
6 months on trial
6 months post-trial
ePRO
2 (0.25-3.75)
2 (0-2.75)
0 (0-3)
SOC
1 (0-2)
2 (1-3)
2 (0.5-3)
Phone Encounters related to Symptoms
6 months prior to trial
6 months on trial
6 months post- trial
ePRO
1 (0-3)
0 (0-2)
0 (0-1)
SOC
1 (0-1.5)
2 (0-2)
2 (2-2)
Patient Electronic Portal Messages
6 months prior to trial
6 months on trial
6 months post- trial
ePRO
2 (1-8.25)
5 (3-7)
4 (2.25-10.5)
SOC
2 (1-5.5)
6 (2.5-11)
5 (1.5-13.5)
Patient Electronic Portal Messages related to Symptoms
6 months prior to trial
6 months on trial
6 months post-trial
ePRO
1 (0-2)
2 (0.25-3.75)
2 (0.35-6)
SOC
1 (0-2)
3 (1.5-7.5)
3 (1-7)
Use of an ePRO platform for symptom reporting in advanced thoracic malignancies was feasible at an academic medical center. While there is concern surrounding ePROs increasing staff workload, we did not notice an increase in overall and symptom related phone calls and electronic patient portal messages. Future directions include analysis from different disease groups and expansion to a second academic center to further understand this tool’s impact on healthcare utilization.
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MA12 - Controversies Old and New (ID 230)
- Event: WCLC 2020
- Type: Mini Oral
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 1/31/2021, 16:45 - 17:45, Scientific Program Auditorium
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MA12.09 - Retrospective Analysis of DIPNECH and Carcinoid Tumorlets as Precursors to Invasive Pulmonary Carcinoid Tumors (ID 1469)
16:45 - 17:45 | Author(s): Sukhmani K. Padda
- Abstract
Introduction
Noninvasive diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH) and carcinoid tumorlets may be precursor lesions to invasive pulmonary carcinoid tumors. These diseases are rare, and as a result their diagnosis, prognosis and management remain unclear.
Methods
A retrospective analysis was performed on patients from our institution with DIPNECH and/or carcinoid tumorlet from 2000 to 2020. Progression of pulmonary nodule(s) associated with DIPNECH/tumorlets to carcinoid tumor was defined radiographically as growth to a size > 5mm. DIPNECH diagnoses were based on either clinical-radiographic features or pathologic review.
Results
A total of 73 patients was identified. Most patients were women (88%), elderly (median age 68 y/o; 44-86), Caucasian (58.9%) and Asian (13.7%); and 50.7% had a smoking history. Symptoms were most commonly cough (61.6%), shortness of breath (53.4%) and no symptoms (20.5%). Overall, 24 patients had at least DIPNECH and 64 patients had at least a tumorlet diagnosed. There was considerable overlap, with 41.1% of patients having more than one diagnosis along the disease spectrum and majority being found within the same pathologic specimen. A total of 12 (16.4%) patients had DIPNECH, tumorlet and carcinoid tumor all found in the same tissue. Treatments for DIPNECH/tumorlets included surveillance (56.9%), inhalers (16.7%), somatostatin analogs (8.3%) and oral steroids (8.3%). Eight (11.6%) patients with DIPNECH and/or tumorlet later developed carcinoid tumor by radiographic criteria, with a median follow up time of 4.7 years. These patients had an eventual pathologic diagnosis of carcinoid tumor.
Conclusion
DIPNECH and tumorlets are possible precursor lesions to pulmonary carcinoid tumors. This study is one of the largest examining these rare diseases to help guide future diagnosis and management. We found that these diseases predominantly affect women irrespective of smoking history, frequently co-occur, and over years may slowly progress to become carcinoid tumors.
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OA03 - Promising Antibody-Drug Conjugate and Cytotoxic Therapy in NSCLC (ID 100)
- Event: WCLC 2020
- Type: Oral
- Track: Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 10:30 - 11:30, Scientific Program Auditorium
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OA03.02 - Chair (ID 4222)
10:30 - 11:30 | Presenting Author(s): Sukhmani K. Padda
- Abstract
Abstract not provided
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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 2
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P76.70 - Afatinib After Progression on Osimertinib in Patients with EGFR-Mutated Lung Adenocarcinoma (ID 3354)
00:00 - 00:00 | Author(s): Sukhmani K. Padda
- Abstract
Introduction
Osimertinib is FDA-approved for frontline treatment of EGFR-mutated non-small cell lung cancer (NSCLC) and for EGFR T790M+ tumors after progression on first- and second-generation EGFR tyrosine kinase inhibitors (TKIs). However, acquired resistance to osimertinib eventually occurs and the standard-of-care treatment after resistance is chemotherapy. Afatinib combined with cetuximab is active in treating EGFR-mutated NSCLC with acquired resistance to first-generation EGFR TKIs, though afatinib monotherapy has minimal activity in this setting. Whether afatinib-containing therapy is active after acquired resistance to the third-generation EGFR TKI osimertinib remains unknown.
Methods
We conducted a single-institution retrospective analysis on patients with stage IV EGFR-mutated lung adenocarcinoma who received afatinib-containing therapies after progression on osimertinib from 03/2017 to 07/2020. Kaplan-Meier curves were generated for survival analyses from the date of afatinib initiation. Response was assessed with RECIST v1.1 criteria. Adverse events were graded according to CTCAE v5.0 criteria.
Results
After progression on osimertinib (N=1 frontline, N=10 2nd-5thline), 11 patients (3 exon19del, 6 L858R, 1 L861Q, 1 exons 18-25 duplication) received afatinib monotherapy (N=2), afatinib + cetuximab (N=7), or afatinib + bevacizumab (N=2). Median number of interval lines of therapy was 1 (range 0-2) and median time from osimertinib discontinuation to afatinib-containing therapy was 6.4 months (range 0.1-11.3). Median progression-free survival (PFS) on afatinib-containing therapy was 2.9 months (95% CI 1.9-not reached [NR]), and median overall survival (OS) was 8.7 months (95% CI 5.7-NR). A PFS ≥ 6 months on osimertinib (N=5) was associated with a significantly greater PFS on afatinib-containing therapy compared to a PFS < 6 months on osimertinib (N=6; median 4.9 versus 1.9 months, log-rank P=0.009). Similar results were observed when excluding the two patients who received afatinib monotherapy. The 6-month PFS threshold on prior osimertinib was not associated with differences in OS on afatinib (median 8.7 versus 8.7 months, log-rank P=0.516). The objective response rate for afatinib was 9.1% (95% CI 0.2-41.3) and the disease control rate was 63.6% (95% CI 30.8-89.1). The most common all-grade adverse events with afatinib were acneiform rash (81.8%), diarrhea (72.7%), dry skin (63.6%), and anorexia (63.6%).
Conclusion
Afatinib-containing therapies have modest activity in treating patients with EGFR-mutated lung adenocarcinoma after progression on osimertinib, with greater activity in patients who achieved a PFS ≥ 6 months on prior osimertinib. Further investigations of afatinib combinations after progression on osimertinib are ongoing, with mechanisms of resistance (i.e., on-target versus bypass tract) being potentially important for this strategy.
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P76.85 - Afatinib and Necitumumab in EGFR mutant NSCLC with Acquired Resistance to 1st or 3rd Generation EGFR Tyrosine Kinase Inhibitors (ID 3547)
00:00 - 00:00 | Presenting Author(s): Sukhmani K. Padda
- Abstract
Introduction
There are no approved targeted therapies for patients (pts) with EGFR mutated NSCLC who develop acquired resistance to frontline 3rd generation (gen) tyrosine kinase inhibitors (TKI) osimertinib (osi), 2nd line osi (T790MPOS after 1st/2nd gen TKI), or frontline 1st/2nd gen TKI and T790MNEG. Dual EGFR blockade with TKI (afatinib) and monoclonal antibody (necitumumab) may overcome resistance in these scenarios.
Methods
This was a phase I 3+3 dose escalation of afatinib plus necitumumab in pts with EGFR mutated NSCLC who progressed on 1st gen TKI (T790MNEG), 1st line osi, and subsequent line osi (T790MPOS after 1st/2nd gen TKI). Afatinib was dosed oral daily and necitumumab dosed IV day 1 and 15 of a 28-day cycle. Dose levels (DL) included: DL1 Afatinib 30 mg, Necitumumab 400 mg; DL2 Afatinib 40 mg, Necitumumab 400 mg; DL3 Afatinib 40 mg, Necitumumab 600 mg; DL4 Afatinib 40 mg, Necitumumab 800 mg. Three dose expansion cohorts (15 pts each in above scenarios) are enrolling at the maximum tolerated dose (MTD).
Results
Enrollment completed in the phase I portion (07/2017-07/2019): 3 DL1, 3 DL2, 3 DL3, and 4 DL4. Four pts progressed on 1st gen TKI (T790MNEG), 1 pt on 1st line osi, and 8 pts on subsequent line osi (T790MPOS after 1st/2nd gen TKI). Two dose limiting toxicities were observed in DL4, including grade (G) 3 diarrhea and symptomatic G3 rash (delayed DLT given occurrence after first 28 days); therefore, DL3 was the MTD. At the time of data cutoff (Aug 26, 2020), 3 pts have enrolled in dose expansion; 1 pt progressed on 1st line osi, 1 pt progressed on 1st gen TKI (T790MNEG), and 1 pt on subsequent line osi (T790MPOS after 1st/2nd gen TKI). The most common treatment-related adverse events of all grades included rash (88%; 2 G3), diarrhea (56%; 1 G3), paronychia (38%; 0 G3), mucositis (31%; 1 G3), fatigue and vomiting (25% each; 0 G3), fever, headache, nausea, and pruritus (23% each; 0 G3). There was no pneumonitis; 1 pt had G1 hypomagnesemia. Six patients required dose reductions, median of 2. While no objective responses were observed in this heavily pre-treated population (median 4 prior lines of therapy), the disease control rate was 38% (6/16) and all pts with stable disease were on treatment ≥15 weeks. Reasons for treatment discontinuation included disease progression (n=14), toxicity (n=1) and pt decision (n=1).
Conclusion
The combination of afatinib and necitumumab had expected toxicities of rash and diarrhea. Trial is ongoing, and the MTD of afatinib 40 mg and necitumumab 600 mg is being tested in 3 dose expansion cohorts.