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T. Shimokawa
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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)
16:45 - 18:15 | Author(s): T. Shimokawa
- 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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P2.11 - Poster Session/ Palliative and Supportive Care (ID 230)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.11-003 - Changes in Quality of Life Through the Early Intervention by a Palliative Care Team for Patients with Advanced Lung Cancer (ID 1098)
09:30 - 17:00 | Author(s): T. Shimokawa
- Abstract
Background:
The change in quality of life (QOL) through the early intervention by a palliative care team was analyzed in patients with advanced lung cancer. The contrast between patients’ own evaluation on their QOL and their QOL estimated by their attending physicians was examined as well.
Methods:
The eligibility criteria were newly-diagnosed Japanese patients with stage IV lung cancer, whose ages were over 20- years old, whose Eastern Cooperative Oncology Group Performance Status were from 0 to 3, and those who had written informed consent. For the patients and attending physicians, QOL questionnaires, which were in line European Organization for Research and treatment of Cancer Quality of Life Questionnaire-Core15 （EORTC QLQ c-15）, were conducted at the time of the enrollment and twelve weeks later. The primary endpoint was a change in global QOL score, which ranged from 0 (worst) to 100 (best), after the twelve-week intervention.
Results:
58 patients out of 96 who were newly diagnosed as stage IV lung cancer were enrolled in this study. 43 patients had the QOL evaluation after twelve weeks. One patient withdrew consent, one patient moved to another hospital and other thirteen patients died during the intervention period. The primary endpoint improved by more than 25% that was originally anticipated (50 points at the enrollment, 64.7 points after the intervention.). All of the following factors including emotional state, nausea, vomiting, pain, constipation improved by more than 25% similarly to the primary endpoints, although other QOL factors showed a slight improvement or no change. While the difference between the QOL score by the patients and the physicians was apparent at the beginning the intervention, it became smaller by every measurement after twelve weeks. In Japan, Palliative care units (PCUs) have a role of hospices as well, and there are not enough number of them, to meet the entire needs for the end-of-life care. Some patients end up dying while on the waiting lists of PCU. Less percentage of patients who had early palliative care (EPC) died while waiting PCU admission, as compared with other cancer patients who applied for PCU during the same period as the present study. (12.5 % vs 30.4 %) In addition, duration of best supportive care in patients were extended approximately one month, as compared with past patients with stage IV lung cancer in undergoing EPC.(108.7day vs 78day)
Conclusion:
QOL improved in studied Japanese patients after the early interventions by the palliative care team. This result may indicate that discrepancy of QOL evaluation between the patients and physicians was lessened due to the early intervention by the palliative care team, which is considered to have fostered the improvement of the overall QOL. It was suggested that such intervention might support the patients in decision making for end-of-life-care.
