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S. Atagi
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MINI 15 - Chemotherapy Developments for Lung Cancer (ID 128)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Crinò, C.P. Belani
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI15.08 - A Phase II Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed in Elderly Patients with Advanced Non-Squamous NSCLC (ID 2453)
17:25 - 17:30 | Author(s): S. Atagi
- Abstract
- Presentation
Background:
Non-small-cell lung cancer (NSCLC) accounts for >80% of all lung cancers, and the risk of lung cancer clearly increases with advancing age. Because of the progressive aging of population, the number of elderly patients with NSCLC is increasing and the desease is becoming an increasing public health problem worldwide. We previously reported a phase I study that recommended a dose of carboplatin (Cb, area under the curve = 5) plus pemetrexed (PEM, 500 mg/m[2]) for elderly (≥75-years-old) patients with non-squamous NSCLC. Furthermore, PEM maintenance therapy, following the combination therapy, was also found to be well tolerated. Therefore, we conducted a multicenter phase II trial to evaluated the efficacy and safety of Cb (area under the curve = 5) plus PEM (500 mg/m[2]) followed by maintenance PEM for elderly (≥75-years-old) patients with non-squamous NSCLC.
Methods:
Treated patients received 4 courses of Cb plus PEM, followed by maintenance PEM, without showing disease progression or severe toxicities. The primary endpoint was the 1-year overall survival (OS) rate, and the secondary endpoints were OS, progression free survival (PFS), response rate (RR), and safety.
Results:
Thirty four patients were enrolled between June 2012 and May 2013. All patients had an ECOG performance status 0 or 1, and adenocarcinoma. The median patient age was 77 years (75-84 years). Twenty four patients were male and ten patients were female. Three patients harbored activating epidermal growth factor recepter mutation (exon19 or 21). The median observation time was 22.7 months. In clinical outcome, the overall RR was 41.2%, and the disease control rate was 85.3%. No patient showed a complete response, 14 showed partial responses, 15 showed stable disease, 4 showed disease progression, and 1 was not evaluated. The maintenance therapy rate was 58.8%. The median PFS for all patients was 5.7 months (95% confidence interval, 3.3–8.5 months), whereas the median OS was 20.5 months (95% confidence interval, 7.8–25.4 months). The 1-year OS rate was 58.0%. In adverse events (total phase of this study), hematological adverse events ≥grade 3 were leucopenia (in 23.5% of patients), neutropenia (55.9%), anemia (35.3%), and thrombocytopenia (20.6%), and major non-hematological adverse events ≥grade 3 were febrile neutropenia (in 8.8% of patients), increased levels of aminotransferase (5.9%), infection (23.5%), and anorexia/fatigue (5.9%). There was 1 treatment-related death due to interstitial lung disease.
Conclusion:
The combination of Cb plus PEM followed by maintenance PEM was effective and reasonably well tolerated in chemotherapy-naïve elderly (≥75-years-old) patients with non-squamous NSCLC. This data was promising and valuable to conduct the phase III study compared with docetaxel (DOC) monotherapy in the first-line setting. Now, the phase III trial compared Cb plus PEM followed by maintenance PEM with DOC for chemotherapy-naïve elderly (≥75-years-old) patients with non-squamous NSCLC (JCOG1210/WJOG7813L: UMIN000011460) is ongoing and the result is warranted. Clinical trial information: UMIN000004810
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P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.07-009 - The Retrospective Analysis of Nab-Paclitaxel Regimens for Relapsed Small Cell Lung Cancer Patients (ID 1384)
09:30 - 09:30 | Author(s): S. Atagi
- Abstract
Background:
Although small cell lung cancer (SCLC) is initially chemo sensitive, most patients rapidly relapse. Prognosis of late line treatment for relapsed SCLC patients is generally poor. The efficacy of paclitaxel regimens for relapsed SCLC patients has been reported in some articles. But no specific study has been reported to our knowledge, about nab-paclitaxel administration for relapsed SCLC patients.
Methods:
By using the database of two hospitals, we underwent a retrospective analysis to evaluate the efficacy and safety of nab-paclitaxel regimens for relapsed SCLC patients. The data of patient characteristics, treatment efficacy and adverse events were collected from the medical records.
Results:
Fourteen patients (3 women and 11 men) with relapsed SCLC were administered weekly nab-paclitaxel or carboplatin plus nab-paclitaxel between February 2013 and July 2014 in our hospitals. The median age was 71 years old. Eight patients had comorbid pulmonary disease (5 had interstitial lung disease, 2 had chronic obstructive pulmonary disease, and 1 had both diseases). Five patients were administered nab-paclitaxel regimen as second line chemotherapy, five patients were as third line and four patients were as fourth or fifth line. Five patients achieved partial response, and four patients had stable disease. The response rate was 36%, and disease control rate was 64%. Most common toxicities were hematological adverse events such as neutrophil count and anemia. Severe neutropenia (Grade 3 or 4) appeared to some patients, but all patients were restored by treatment. The main non-hematologic adverse events were neurotoxicity and constipation, and these events were mild.
Conclusion:
The administration of nab-paclitaxel regimens to highly treated patients with relapsed SCLC demonstrated modest response rate and disease control rate. All adverse events were manageable, so that nab-paclitaxel regimens were well tolerated. Further clinical trial to evaluate the efficacy and safety of nab-paclitaxel regimens for relapsed SCLC patients is warranted.
