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Koichi Goto
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MA 17 - Locally Advanced NSCLC (ID 671)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:S. Jheon, Georgios Stamatis
- Coordinates: 10/17/2017, 15:45 - 17:30, F203 + F204 (Annex Hall)
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MA 17.06 - Safety Data from Randomized Phase II Study of CDDP+S-1 vs CDDP+PEM Combined with TRT for Locally Advanced Non-Squamous NSCLC (ID 8296)
15:45 - 17:30 | Author(s): Koichi Goto
- Abstract
- Presentation
Background:
Both cisplatin (CDDP)+S-1 and CDDP+pemetrexed (PEM) can be given at full systemic doses with thoracic radiotherapy (TRT) in locally advanced non-small cell lung cancer (NSCLC), and CDDP+PEM is one of the standard chemotherapy regimens in patients with advanced non-squamous (non-sq) NSCLC. This multicenter, randomized, open-label, phase II study (SPECTRA) compared the efficacy and safety of the two above-mentioned promising regimens combined with TRT in patients with unresectable locally advanced non-sq NSCLC.
Method:
Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. If the 2-year PFS rate is assumed to be 25% in the inferior therapy group and 15% higher in the superior therapy group of this study, the sample size needed for selection of the optimum treatment group at a probability of approximately 95% will be 51 cases/group with the Simon’s selection design. The sample size was set at 100 patients.
Result:
Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n=17 (33%)/n=17 (34%); stage IIIB, n=21 (40%)/n=20 (40%); ECOG PS of 1, n=14 (27%)/n=14 (28%); never smoker, n=12 (23%)/n=12 (24%); and adenocarcinoma, n=47(90%)/n=45(90%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64%. Grade 3 or higher toxicities included febrile neutropenia (12%/2%), anorexia (8%/16%), diarrhea (8%/0%), esophagitis (6%/8%), pneumonia (4%/4%), neutropenia (38%/52%), anemia (8%/12%), thrombocytopenia (4%/6%), and hyponatremia (12%/12%). Grade 1 radiation pneumonitis was observed in 8 (15%)/2 (4%) patients on the basis of the data collected 30 days or less after the discontinuation of protocol treatment. No treatment-related death was observed. The data on PFS and overall survival are immature.
Conclusion:
Response rate was similar between the two arms. Toxicities were tolerable and manageable in both arms; however febrile neutropenia was more frequently observed in the CDDP+S-1 arm. We will present the updated safety data of this study at the conference. Survival data will be analyzed in late 2018.
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MTE 21 - Search for Novel Driver Mutations (Sign Up Required) (ID 570)
- Event: WCLC 2017
- Type: Meet the Expert
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 07:00 - 08:00, Room 315
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MTE 21.01 - Novel Driver Mutations for Lung Cancer (ID 7805)
07:00 - 08:00 | Presenting Author(s): Koichi Goto
- Abstract
- Presentation
Abstract not provided
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-027 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR Study) (ID 8490)
09:30 - 16:00 | Author(s): Koichi Goto
- Abstract
Background:
The study objective was to compare efficacy and safety of CBDCA+PTX+BEV and CDDP+PEM+BEV in non-squamous (non-Sq) NSCLC patients.
Method:
Treatment-naïve patients aged 20-74 with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC were randomly assigned at 1:2 ratio to either treatment A (4 cycles of CBDCA [AUC 6] + PTX [200mg/m[2]] + BEV [15mg/kg] q3wk, and maintenance therapy with BEV q3wk until progression) or treatment B (4 cycles of CDDP [75mg/m[2]] + PEM [500mg/m[2]] + BEV q3wk, and maintenance therapy with PEM + BEV until progression). The primary endpoint was PFS by central review. The secondary endpoints included OS and safety profile. Target enrollment number was 210.
Result:
A total of 55 sites across Japan enrolled 199 patients: 67/132 (A/B). The median age was 67/66 years, 70%/74% were male, 54%/52% were PS 0, 75%/73% were stage IV and 93%/98% had adenocarcinomas. As of April 14, 2017, patients had completed a median of 7/8 treatment cycles, while 94%/80% had discontinued treatment. The most common ≥G3 adverse events were neutropenia (75%/24%), and hyponatraemia (6%/10%). The most common BEV-related adverse events (≥G1) were hypertension (44%/58%), proteinuria (52%/43%) and epistaxis (26%/14%). Dose reduction was necessary due to an adverse event in 31%/22% patients. Treatment-related death (pulmonary infection) was reported in 1 patient receiving treatment B.
Conclusion:
CBDCA+PTX+BEV and CDDP+PEM+BEV had different safety profiles. Efficacy results including the primary endpoints will be presented in 2018.
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P2.15 - SCLC/Neuroendocrine Tumors (ID 716)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.15-004 - Underrepresentation of Elderly Patients with ED-SCLC as Clinical Trial Candidates (JCOG1201/TORG1528) (ID 8837)
09:30 - 16:00 | Author(s): Koichi Goto
- Abstract
Background:
Since December 2013, we initiated a phase II/III trial [Japan Clinical Oncology Group (JCOG) 1201/Thoracic Oncology Research Group (TORG) 1528: UMIN000012605] for elderly patients with extensive-disease small-cell lung cancer (ED-SCLC). Aim of the study is to demonstrate that a carboplatin plus irinotecan regimen is superior to carboplatin plus etoposide in elderly patients with ED-SCLC. However, the patient accrual rate did not satisfactorily match our expectations a year from the time of initiation of our study. To define factors related to low accrual, we searched institutional records and analyzed.
Method:
We collected data of elderly patients with ED-SCLC from each institution and investigated the total number of elderly patients with ED-SCLC, number of patients eligible/ineligible for the study, numbers of patients registered for the study, and the reasons for non-registration of even eligible patients. Doctor-reported questionnaires concerning elderly (≥71 years old) ED-SCLC patients diagnosed in their institutions were sent to chief or coordinate doctors at each institution in December 2014.
Result:
We received a response from 32 (84%) of 38 institutions. Approximately 260 patients were diagnosed as elderly patients with ED-SCLC in the last year. Only 100 patients (38%) were eligible for the JCOG 1201/TORG1528 trial. Reasons for ineligibility primarily included poor performance status (PS) (25%), low organ functions (25%), interstitial pneumonitis (19%) and double cancer (18%). Only 23 patients among the 100 eligible candidates accrued to the study. The primary reasons for non-accrual were delayed approval from the Institutional Review Board (IRB) of the individual institution (24%), physician preferences (23%), patient refusal (18%), and registration for other trials (12%).
Conclusion:
Our data demonstrated that 62% of ED-SCLC patients were ineligible for the protocol due to frailty with the most frequent reason being comorbidities such as poor PS and low organ functions. However, inactive institutions need to increase their efforts to register a greater number of eligible patients in addition to obtaining quicker IRB approval of protocol. Based on responses to questionnaires sent out as part of our investigation, in January 2016, the protocol was revised in terms of eligibility criteria to enhance patient accrual. Eligibility criteria for participation of elderly patients with ED-SCLC need to be formulated prudently so that patients are benefitted in routine clinical practice.
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P3.02 - Biology/Pathology (ID 620)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.02-074 - Podoplanin-Positive CAF Is Associated with a Higher Number of Single Nucleotide Variants in Cancer Cells in Lung Adenocarcinoma (ID 9885)
09:30 - 16:00 | Author(s): Koichi Goto
- Abstract
Background:
Podoplanin-positive cancer-associated fibroblasts (CAFs) play an essential role in tumor progression. However, it is still unclear whether specific genomic alterations of cancer cells are required to recruit podoplanin-positive CAFs. The aim of this study was to investigate the relationship between the mutation status of lung adenocarcinoma cells and the presence of podoplanin-positive CAFs.
Method:
Ninety-seven lung adenocarcinomas for which whole exome sequencing data were available were enrolled. First, we analyzed the clinicopathological features of the cases with podoplanin-positive CAFs, and then, we evaluated the relationship between genetic features of cancer cells (major driver mutations and the number of single nucleotide variants, or SNVs) and the presence of podoplanin-positive CAFs.
Result:
Patients with podoplanin-positive CAFs had a significantly lower 5-year recurrence-free proportion than those with podoplanin-negative CAFs (p = 0.027). We could not find any significant correlations between major genetic mutations (EGFR, KRAS, TP53, MET, ERBB2, BRAF, and PIC3CA) in cancer cells and the presence of podoplanin-positive CAFs. However, cases with podoplanin-positive CAFs had a significantly higher number of SNVs in cancer cells than the podoplanin-negative CAFs cases (median; 84 vs 37, respectively; p = 0.001). This was also detected in a non-smoker subgroup (median: 64 vs 32, respectively; p = 0.037). Multivariate analyses revealed that the number of SNVs in cancer cells was the only statistically significant independent predictor for the presence of podoplanin-positive CAFs (p = 0.044).
Conclusion:
In lung adenocarcinoma, the presence of podoplanin-positive CAFs was associated with higher numbers of SNVs in cancer cells, suggesting a relationship between accumulations of SNVs in cancer cells and the generation of a tumor- promoting microenvironment.
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P3.14 - Radiotherapy (ID 730)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.14-001 - Impact of PCI on Prognosis of LD-SCLC Through Pattern of Brain Metastases as a First Recurrence Site (ID 9648)
09:30 - 16:00 | Author(s): Koichi Goto
- Abstract
Background:
Brain metastases frequently occur in patients with small-cell lung cancer. Therefore, prophylactic cranial irradiation (PCI) is recommended for good responders of initial treatment. The purpose of this study was to investigate influence of PCI on pattern of brain metastases as a first recurrence site (BMFR) after radical treatment for limited disease small-cell lung cancer (LD-SCLC).
Method:
This retrospective study included LD-SCLC patients treated with thoracic radiotherapy and concurrent chemotherapy between January 2006 and December 2014. Induction chemotherapy was permitted. Thoracic radiotherapy was performed with accelerated hyper-fractionated radiotherapy (twice daily, 45 Gy in 30 fractions over 3 weeks) or conventional-fractionated radiotherapy (once daily, 50 Gy in 25 fractions over 5 weeks). Regimen of chemotherapy consisted of intravenous platinum-etoposide.
Result:
One hundred and sixty-two patients were included in this study. The median follow-up duration for surviving patients was 38 months (range, 6-105 months). Among 123 patients (76%) who died, 104 patients died due to disease progression, 11 died due to unknown cause and 8 died due to other cause. Ninety-three patients (57%) underwent PCI, and the 3-year disease specific survival (DSS) rates were 20%(12-35) in patients without PCI and 43%(33-55) in those with PCI (p<0.001). Concerning the recurrence pattern, the frequency of BMFR was significantly higher in patients who did not underwent PCI compared with those who did (49% vs 25%, p=0.008) although no significant difference in frequency of all site of recurrence was observed between patients without PCI and those with PCI (83% vs 73%, p=0.109). Regarding the impact of BMFR on prognosis, patients with BMFR exhibited significant shorter DSS than those whose first recurrence sites was other than brain metastases (3yr-DSS 6% vs 22%, p=0.007), and patients who developed BMFR without PCI exhibited significant lower DSS compared with those who developed BMFR with PCI (3yr-DSS 0% vs 17%, p=0.005). In addition, 68% of patients who did not underwent PCI exhibited multiple BMFR lesions with 5 or more while 12% of patients who did (p<0.001).
Conclusion:
The results of this study indicated that BMFR exhibited significant negative impact on prognosis after radical treatment for LD-SCLC and the difference in the number of metastatic lesions in BMFR between patients with PCI and those without PCI might affect clinical outcomes.
