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H. Minemura
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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. Minemura
- 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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P1.11 - 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. Minemura
- 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.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-074 - Phase II Trial of Erlotinib Monotherapy for Pretreated Elderly Patients with Advanced EGFR Wild-Type Non-Small-Cell Lung Cancer (ID 188)
09:30 - 09:30 | Author(s): H. Minemura
- Abstract
Background:
In industrialized countries, the age of approximately 50% of patients at diagnosis of non-small cell lung cancer (NSCLC) is >70 years old. Exploration of an optimal treatment strategy for elderly patients with NSCLC as either a first-line or second-line therapy is required. Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is an effective treatment for patients with NSCLC, especially those harboring activating EGFR mutations. A previous phase III trial suggested that patients with EGFR wild-type (EGFR-wt) NSCLC or elderly patients with disease progression after cytotoxic chemotherapy might benefit from erlotinib monotherapy. However, few studies have prospectively evaluated the efficacy and safety of second or third-line erlotinib monotherapy in elderly patients with EGFR-wt advanced or recurrent NSCLC.
Methods:
Eligibility criteria included: patients aged ≥70 years with pathologically or cytologically proven NSCLC; measurable tumor sites according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1; an Eastern Cooperative Oncology Group performance status of 0–2; no activating EGFR gene mutations (exon 18, 19, 20 and 21); history of 1–2 regimens of systemic chemotherapy; stage IIIB or IV NSCLC, or postoperative recurrence; treatment naïve to EGFR-TKI; and appropriate organ function. EGFR gene mutation analysis was performed by using invasive signal amplification reaction with a structure-specific 5’ nuclease and a polymerase chain reaction (PCR) product (PCR-invader). Patients received oral erlotinib at a dose of 150 mg/day until disease progression. Primary outcome was the objective response rate (ORR). Secondary end points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and toxicity profile.
Results:
This study was terminated early because of the results from a Japanese phase III trial (DELTA trial). Sixteen patients were enrolled between April 2010 and May 2013. The median age was 78 years (range, 70–84 years), and six patients were female. Five patients had an Eastern Cooperative Oncology Group performance status of 0, and 11 (69%) patients had adenocarcinoma. Fifteen (94%) patients were treated with erlotinib as a second-line therapy. The ORR was 0% (95% confidence interval [CI]: 0–17.1) and DCR was 56.3% (95% CI: 33.2–76.9). The median PFS and OS were 1.7 months (95% CI: 1.3–2.2) and 7.2 months (95% CI: 5.6-8.7), respectively. The most commonly occurring adverse events included acneiform eruption (31.3%) and skin rash (25.0%). One patient developed grade 3 interstitial lung disease, which was improved by following steroid therapy.
Conclusion:
In pretreated elderly patients with advanced or recurrent EGFR-wt NSCLC, daily oral erlotinib was well tolerated; however, administration of the drug should not be considered as a second-line therapy.
