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H. Yokouchi
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-050 - Clinical Features of Non-Squamous Non-Small-Cell Lung Cancer Patients Treated with Long-Term Pemetrexed (ID 1618)
09:30 - 09:30 | Author(s): H. Yokouchi
- Abstract
Background:
It has been generally accepted that pemetrexed (PEM) with platinum followed by PEM maintenance therapy is a standard first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NS-NSCLC). The number of patients treated with long-term use of PEM is increasing, and thus we should know the clinical features including side effects in those patients. Belen et al. reported that skin toxicities were related to PEM maintenance therapy, while Jean et al. demonstrated that 7.8% of patients receiving maintenance PEM had grade 1/2 edema in the PARAMOUNT trial. Further investigation into clarifying the clinical features of these patients is required.
Methods:
We retrospectively reviewed the charts of 13 patients with advanced NS-NSCLC who had been treated with long-term PEM (10 and more courses) in our hospital between July 2009 and December 2014.
Results:
All patients had adenocarcinoma. The median age was 63 years (range: 39-72). Six patients were male, and six were never-smokers. All but one patient were classified as clinical stage IV. Six patients harbored EGFR mutation and one patient had ALK gene rearrangement. Twelve patients received PEM with platinum (cisplatin; seven patients, carboplatin; five patients), and one patient received PEM alone. The median number of courses of PEM was 16 (range: 10-21). Grade 3/4 non-hematological toxicities observed in the 13 patients were anorexia (8%), nausea (8%), and dizziness (15%). Grade 3/4 hematological toxicities observed were neutropenia (46%), anemia (15%), and thrombocytopenia (15%). Two patients had peripheral skin edema; one patient developed eyelid edema at 21 cycles of PEM, and the other developed limb edema and pleural fluid at 20 cycles of PEM. Four patients underwent PEM beyond RECIST PD following platinum-based doublet chemotherapy regimen (CDDP+PEM; 2, CBDCA+PEM; 2). Initial response by the induction chemotherapy was PR in two patients and SD in two patients. The PD sites were lungs in two patients, bone in one patient and adrenal gland in one patient. The median post progression survival (PPS) of each of the four patients was 205.5 days (range; 68-330). All the four patients underwent PEM until “clinical” PD. Progressive sites were lungs in two patients, bone in one patient and esophagus in one patient. The median duration between RECIST PD and clinical PD was 100.5 days (range; 35-210).
Conclusion:
The differential profile of adverse effects, including dizziness and edema, driven by long-term PEM compared with those by conventional use of PEM suggested that we should cautiously select supportive therapies for NSCLC patients who are being treated with long-term PEM. Continuation of PEM beyond PD can be in consideration for selective patients with NS-NSCLC, as observed in patients treated with EGFR-TKI.
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P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.07-006 - Final Results of Randomized Phase II Study of Carboplatin plus Irinotecan vs. Carboplatin plus Amrubicin for ED-SCLC (ID 931)
09:30 - 09:30 | Author(s): H. Yokouchi
- Abstract
Background:
Carboplatin-based regimens, such as carboplatin plus etoposide (CE), are among the standard regimens for the management of extended disease small-cell lung cancer (ED-SCLC). However, the efficacy of carboplatin-based regimens is unsatisfactory. Carboplatin plus irinotecan (CI) and carboplatin plus amrubicin (CA) are promising new carboplatin-based regimens identified in our previous studies. Accordingly, we conducted this randomized phase II study to identify the appropriate regimen for comparison with CE in future phase III trials.
Methods:
Chemotherapy-naïve patients with ED-SCLC were randomly assigned to receive 4–6 cycles of carboplatin (area under the curve [AUC] 5.0, day 1) plus irinotecan (70 mg/m[2], days 1 and 8) every 3 weeks (CI arm) or carboplatin (AUC 4.0, day 1) plus amrubicin (35 mg/m[2], days 1–3) every 3 weeks (CA arm). The primary endpoint was the overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity.
Results:
Between December 2009 and March 2013, 71 patients were enrolled. One patient in each arm did not receive any protocol treatment owing to rapid disease progression. The characteristics of the treated patients were as follows: median age, 70 years (range 51–84 years) and proportion of males, 84%. Delivered mean dose intensities (mean actual dose/mean planned dose) were similar for both arms: carboplatin 98% and irinotecan 94% for CI arm, and carboplatin 97% and amrubicin 94% for CA arm. The ORRs were 79% and 89%, median PFS was 5.1 and 6.2 months (CA; hazard ratio [HR] = 0.59, 95% CI: 0.35–0.98, P = 0.042), and median OS was 12.2 and 15.9 months in the CI and CA arms, respectively (CA; HR, 0.77; 95% CI: 0.49–1.29; P =.318). Grade 3 or higher neutropenia (CI, 53% and CA, 89%), anemia (CI, 26% and CA, 20%), thrombocytopenia (CI, 18% and CA, 14%), and febrile neutropenia (CI, 12% and CA, 29%) were observed. No treatment-related deaths were observed. Overall, 25 patients (74%) in the CI arm and 28 patients (80%) in the CA arm received post-discontinuation therapies.
Conclusion:
CA was numerically effective than CI in chemotherapy-naïve patients with ED-SCLC, with acceptable toxicity. Therefore, CA could be selected for future phase III trials.
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P1.11 - Poster Session/ Palliative and Supportive Care (ID 229)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.11-011 - Taste Disorder in Patients with Thoracic Malignancy Who Received Chemotherapy (ID 1322)
09:30 - 09:30 | Author(s): H. Yokouchi
- Abstract
Background:
Recent development of novel cancer treatments have enabled patients to have prolonged survival; however, some patients cannot receive benefits from those effective therapies because of severe adverse effects. One of the major adverse effects that are recognized by medical staff in patients who undergo chemotherapy is taste disorder, although little is known about how to treat it. To overcome this problem, accumulating fundamental data, such as incidence rate and timing of taste disorder in cancer patients who have undergone chemotherapy, is necessary. With this in mind, we attempted to collect the data regarding taste disorder in patients with thoracic malignancy after initiation of chemotherapy as a pilot study, in order to determine the primary endpoint for subsequent intervention studies.
Methods:
All eligible patients had treatment-naive non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC) or malignant pleural mesothelioma (MPM) with ECOG performance status (PS) 0-2, and underwent chemotherapy. Written informed consent was obtained from all participants. We prospectively investigated the incidence rate and timing of taste disorder in these patients using the following two methods: i) analysis of gustatory threshold for salty taste using a sodium-impregnated test strip (SALSAVE, Advantec Toyo Co. Ltd., Tokyo, Japan); and ii) analysis of responses of a questionnaire which asked about the patient’s appetite, the timing of each taste change (sweet, salty, sour, and bitter taste), the presence of a taste in the mouth without eating any food, changes in sense of smell, tolerability against taste disorder, and the condition of the mouth and stomach after each cycle (1-4 cycles) of chemotherapy. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry, identification number UMIN00007879, and approved by the Institutional Review Board of our institution.
Results:
From June 2012 to August 2014, 36 pts were enrolled. The average age was 64.5 years (range: 37-83); male/female=29/7 (81/19%); ECOG PS 0/1/2=20/12/1 (56/33/3%); NSCLC/SCLC/MPM=25/8/3 (69/22/8%), clinical stage IIIA/IIIB/IV/adjuvant of lung cancer =2/6/23/2 (6/18/70/6%), and IMIG stage III/IV of MPM=2/1. Chemotherapy regimens were as follows; cisplatin/carboplatin/pemetrexed/etoposide/ paclitaxel/others=18/14/16/8/3/7. There was a trend of increased threshold for salty taste detected by a test strip after one or two cycles of chemotherapy (p=0.10, each). Questionnaire analysis demonstrated that patients felt changes in taste after two or three cycles of chemotherapy (p=0.04, 0.005, respectively), felt changes in their sense of smell after one to three cycles (p=0.04, 0.002, 0.001, respectively), and had a reduced sensitivity to salty tastes after three cycles (p=0.02).
Conclusion:
These results suggest that using a salt test strip may detect salty taste disorder earlier than analysis of the patient’s subjective symptoms as answered in a questionnaire. The questionnaire evidently demonstrated taste disorder from various aspects in patients with thoracic malignancy receiving chemotherapy, and thus intervention using novel drugs is necessary. Further accumulation of such data is definitely warranted for further studies.
