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K. Nosaki
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-097 - Experience of Re-Biopsy (Biopsy at Progression) of EGFR Mutant Non-Small Cell Lung Cancer Patients in Japan: A Retrospective Study (ID 4049)
14:30 - 14:30 | Author(s): K. Nosaki
- Abstract
Background:
To confirm mechanisms of resistance to targeted therapy and to evaluate future treatment strategy, biopsy at progression is important and necessary. Since biopsy at progression is not standard of care, we investigated real-world clinical practice in Japanese patients with non-small cell lung cancer (NSCLC) patients harboring the epidermal growth factor receptor (EGFR) gene mutation.
Methods:
This was a retrospective, multi-center, observational study in Japan. EGFR mutation positive NSCLC patients who developed disease progression after treatment by EGFR tyrosine kinase inhibitor were enrolled. The primary objective was the success rate of re-biopsy (biopsy at progression). The secondary objectives were differences of between the first biopsy and re-biopsy (e.g. sampling method, target organ of biopsy) and complications associated with re-biopsy.
Results:
395 patients were evaluated, median age was 63 years, and the most common histological type was adenocarcinoma (96.2%). Success rate of re-biopsy was 79.5% (314/395) of patients. Compared with the first biopsy, surgical biopsy increased from 1.8% to 7.8%, percutaneous tissue biopsy increased from 7.6% to 29.1%. Most commonly performed gene mutation tests using specimen collected by re-biopsy were EGFR (94.3%), EML4-ALK (22.0%) and KRAS (14.3%). T790M mutation was detected in 147 (49.7 %) out of 296 patients. 23 patients (5.8%) had complications associated with re-biopsy, the most common complication was pneumothorax. A repeated re-biopsy was successful in 87.5% (28/32) of patients.Table. Re-biopsy success rate by site and sampling method No. of patients Success rate (%) By Site Primary site 220 168 (76.4%) Metastatic site 121 103 (85.1%) Lymphnodes 50 40 (80.0%) Others 4 3(75.0%) By sampling method Transbronchial biopsy; forceps 204 147(72.1%) Transbronchial biopsy; needle 41 34 (82.9%) Percutaneous needle biopsy under CT guidance 77 66 (85.7%) Percutaneous needle biopsy under ultrasonic guidance 36 34 (94.4%)
Conclusion:
The observed success rate of re-biopsy was approximately 80% in this study. T790M detection rate was comparable to the previously reported studies. Re-biopsy for the EGFR TKI failure NSCLC patients is feasible in Japan.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-001 - Phase I Study of Salazosulfapyridine Targeting Cancer Stem Cells in Combination with CDDP and Pemetrexed for Chemo-Naïve Advanced Non-Sq NSCLC (ID 4318)
14:30 - 14:30 | Author(s): K. Nosaki
- Abstract
Background:
Variant splicing isoforms of CD44 (CD44v) are a marker of cancer stem cells (CSCs) in solid tumors. CD44v stabilizes the glutamate-cystine transporter subunit xCT and thereby promotes synthesis of the intracellular antioxidant glutathione and protects CSCs from oxidative stress. Salazosulfapyridine (SASP) is an inhibitor of xCT activity, and, in combination with cisplatin (CDDP), it attenuates the increase in the proportion of CD44v-positive tumor cells during the growth of tumor xenografts in mice.
Methods:
Individuals with advanced (stage IIIB or IV) nonsquamous non–small cell lung cancer are eligible to enroll in a phase I dose-escalation study (standard 3+3 design) of SASP in combination with CDDP and pemetrexed (PEM) as first-line treatment. Patients receive SASP daily as well as CDDP (75 mg/m[2]) and PEM (500 mg/m[2]) on day 1 of a 21-day cycle. The primary end point is the percentage of patients who experience dose-limiting toxicity (DLT) between administration of the first dose of SASP (day 1) and day 21.
Results:
From April 2015 to January 2016, 15 patients were enrolled in the study (mean age, 64 years; age range, 42–74 years; male/female ratio, 10/5; ECOG performance status 0/1 ratio, 6/9). Immunohistochemical staining of tumor biopsy specimens revealed that the proportion of CD44v-positive cells was >10% in 9 patients before SASP treatment. No DLT was observed in the first three patients treated at SASP dose level 1 (500 mg TID) or those treated at dose level 2 (1000 mg TID). At dose level 3 (1500 mg TID), two of three patients experienced a DLT (anorexia of grade 3). We enrolled additional patients at dose level 2 and two of the total of five patients treated at this dose level experienced DLTs (hypotension or pneumonitis, each of grade 3). To confirm the safety of dose level 1, we enrolled additional patients at this dose level and one of the total of six patients treated at this dose level experienced DLTs (AST and ALT elevation, each of grade 3). Exposure of SASP following oral administration varied markedly among individuals according to ABCG2 and NAT2 genotypes as previously reported.
Conclusion:
SASP 500 mg TID was the recommended dose when administered with CDDP plus PEM.
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P3.05 - Poster Session with Presenters Present (ID 475)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Palliative Care/Ethics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.05-007 - Prospective Evaluation for Combination Antiemetic Therapy on CINV in NSCLC Receiving Carboplatin-Based Chemotherapy of MEC (ID 3737)
14:30 - 14:30 | Author(s): K. Nosaki
- Abstract
Background:
The incidence of delayed chemotherapy-induced nausea and vomiting (CINV) for non-small cell lung cancer (NSCLC) patients receiving carboplatin (CBDCA) -based chemotherapy (CBDCA+pemetrexed (PEM) / CBDCA+ paclitaxel (PTX)) has not been clearly controlled.
Methods:
We used the combined data from the two prospective observational studies; A nationwide survey of CINV study group and the other prospective observational study in Japan. We assessed whether delayed CINV were controlled with combination antiemetic treatment. We also evaluate risk factors by logistic regression analysis.
Results:
A total of 240 patients were evaluable in this study. The median age was 66 (range:34-82) with 173 males and 67 females. Three antiemetics were used in 54 (22.5%) patients. Delayed nausea and vomiting were experienced more commonly in women than in men. Delayed nausea was well controlled with 3 antiemetics than with 2 antiemetics for women (45.0% vs. 72.3%; P=0.0506). Delayed vomiting was well controlled with 3 antiemetics than with 2 antiemetics for overall (11.1% vs. 23.1%; P=0.0571) and for women (20.0% vs. 44.7%; P=0.0962). We identified several risk factors; women (OR=2.903 ;95% confidence interval [CI], 1.607-5.242 ;P=0.0004) and age (OR=0.968 ;95%CI, 0.938-0.999 ;P=0.0442) for delayed nausea, and women (OR=4.252 ;95%CI, 2.154-8.394 ;P<0.0001) and 2 antiemetics (OR=3.140 ;95%CI, 1.205-8.179 ;P=0.0192) for delayed vomiting.
Conclusion:
Three antiemetics combination are encouraged for NSCLC patients treated with CBDCA-based chemotherapy to alleviate delayed vomiting.
