Dataset Information

Consolidation With Pembrolizumab and Nab-Paclitaxel After Induction Platinum-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer.

ABSTRACT:

Background

Induction with four cycles of platinum-based chemotherapy was the standard of care for metastatic non-small cell lung cancer (NSCLC) until the approval of immune checkpoint blockade (ICB) in the first-line setting. Switch maintenance therapy has shown promise in improving survival by exposing patients to novel, non-cross-resistant agents earlier in their treatment course.

Methods

We performed this open-label, three-arm, randomized phase II study (NCT02684461) to evaluate three sequences of consolidation with pembrolizumab and nab-paclitaxel in patients without progressive disease post induction chemotherapy. Consolidation was either sequential with pembrolizumab for four cycles followed by nab-paclitaxel for four cycles (P→A), nab-paclitaxel followed by pembrolizumab (A→P), or concurrent nab-paclitaxel and pembrolizumab for four cycles (AP).

Results

Twenty patients were randomized before the study was closed early due to the approval of first-line checkpoint inhibitors. We found that consolidation is feasible and well tolerated, with 30% of patients experiencing grade 3 toxicity. The median progression-free survival and OS in months (95% CI) in P→A were 10.1 (1.5-NR), 27.6 (1.7-NR); 8.4 (1.2-9.0), 12.7 (4.4-NR) in A→P; and 10.2 (5.1-NR), NR. Quality of life as measured by FACT-L improved in the majority of patients during the course of the study.

Conclusion

Sequential and concurrent consolidation regimens are well tolerated and have encouraging overall survival in patients with metastatic NSCLC.

SUBMITTER: Patel SA

PROVIDER: S-EPMC8074674 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Consolidation With Pembrolizumab and Nab-Paclitaxel After Induction Platinum-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer.

Patel Shetal A SA Gerber David E DE Deal Allison A Douglas Kathe K Pecot Chad V CV Lee Carrie C Schiller Joan J Dhruva Nirav N Weiss Jared J

Frontiers in oncology 20210412

<h4>Background</h4>Induction with four cycles of platinum-based chemotherapy was the standard of care for metastatic non-small cell lung cancer (NSCLC) until the approval of immune checkpoint blockade (ICB) in the first-line setting. Switch maintenance therapy has shown promise in improving survival by exposing patients to novel, non-cross-resistant agents earlier in their treatment course.<h4>Methods</h4>We performed this open-label, three-arm, randomized phase II study (NCT02684461) to evaluat ...[more]

PMID: 33912470

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Project description:IntroductionDespite improvements in the treatment of advanced non-small cell lung cancer (NSCLC), certain patient populations remain underrepresented in clinical trials. Many patients have benefited from platinum doublets, including nab-paclitaxel-based regimens, but there are patients with comorbidities who particularly require careful balancing of efficacy and safety. Clinical trial data are limited for patients who are elderly or have renal impairment, diabetes, or impaired performance status.MethodsTo better understand outcomes in these patient populations, we performed a pooled analysis using data from the ABOUND clinical trial program (ABOUND.SQM, ABOUND.PS2, ABOUND.70+) and the key phase III trial of nab-paclitaxel/carboplatin in advanced NSCLC. The populations included in this pooled analysis consisted of elderly patients (≥ 70 years) and patients with renal impairment (eGFR < 60 ml/min/1.73 m2), diabetes, or poor performance status (ECOG PS 2).ResultsMedian progression-free survival (PFS) ranged from 4.1 months in patients with ECOG PS 2 (95% CI, 2.04-5.09 months) to 7.7 months in patients with diabetes (95% CI, 5.88-10.12 months). PFS for elderly patients and patients with renal impairment was 6.9 months each (95% CI, 6.01-7.98 months and 4.47-9.79 months, respectively). Median overall survival (OS) was 18.2 months (95% CI, 10.94-28.22 months), 17.4 months (95% CI, 14.59-20.14 months), and 16.1 months (95% CI, 14.09-18.50 months) in patients with renal impairment, patients with diabetes, and elderly patients, respectively. Patients with ECOG PS 2 exhibited the shortest median OS: 5.6 months (95% CI, 3.98-11.37 months). Overall response rates were 56.9%, 54.6%, 45.9%, and 29.4% in patients with diabetes, elderly patients, patients with renal impairment, and patients with ECOG PS 2, respectively. Most treatment-related adverse events were hematologic. The most common grade 3/4 hematologic adverse events in patients with renal impairment, elderly patients, patients with diabetes, and patients with poor performance status included neutropenia, anemia, and thrombocytopenia.ConclusionsAlthough survival data in patients with ECOG PS 2 were notably inferior to the other cohorts, our findings are consistent with those previously reported in the population-specific studies of the ABOUND trials and lend additional support for the use of nab-paclitaxel-based regimens in historically understudied and vulnerable populations.

Project description:Background Pembrolizumab has been shown to have a powerful benefit for locally advanced or metastatic esophageal cancer. The aim of present study was to evaluate the efficacy and safety of pembrolizumab combined with neoadjuvant chemotherapy for locally advanced and potentially resectable esophageal squamous cell carcinoma (ESCC). Methods Patients diagnosed with clinical stage III-IV ESCC and have a chance of resectability at Fujian Provincial Hospital were included into this study. Patients received pembrolizumab in combination with paclitaxel and nedaplatin as induction therapy once every 3 weeks in the first stage. After 4 cycles of pembrolizumab therapy, the patients then chose to undergo radical surgery (group A), radical radiotherapy (group B), or neither (group C). In the third stage, maintenance treatment with pembrolizumab was administered to all patients. Results A total of 39 patients (33 male and 6 female) with a median age of 64 years were included. After immune response evaluation in the first stage, 34 (87.2%) patients achieved immune partial response (iPR), and 5 (12.8%) patients achieved immune stable disease (iSD). The objective response rate (ORR) was 87.2% (34/39), and the disease control rate (DCR) was 100%. In the second stage, 22 patients received radical surgery, all of whom achieved R0 resection. The major pathological response (MPR) rate was 68.2% (15/22), and the pathological complete response (pCR) rate was 45.5% (10/22). Of the patients, 9 chose radiotherapy as the radical therapeutic method and 8 chose not to undergo any radical therapy. The median period of pembrolizumab therapy was 8 cycles (4–22 cycles). The median follow-up time was 14 months (3–34 months). The median overall survival and progression-free survival (PFS) times were not reached. The incidence of severe adverse events (AEs) (grade ≥3) was 15.4% (6/39). Conclusions Pembrolizumab combined with paclitaxel and platinum for locally advanced and potentially resectable ESCC has a high ORR, high surgical conversion, MPR, pCR, and R0 resection rates, and tolerable AEs. Also, pembrolizumab could provide good benefits in sequential treatment with radical radiotherapy or maintenance therapy.

Dataset Information

Consolidation With Pembrolizumab and Nab-Paclitaxel After Induction Platinum-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer.

Background

Methods

Results

Conclusion

Publications

Consolidation With Pembrolizumab and Nab-Paclitaxel After Induction Platinum-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer.

Similar Datasets

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