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OA15 - Sublobar Resections for Early Stage NSCLC (ID 396)
- Event: WCLC 2016
- Type: Oral Session
- Track: Surgery
- Presentations: 1
OA15.01 - Limited Resection Trial for Pulmonary Sub-solid Nodules: Case Selection Based on High Resolution CT: Outcome at Median Follow-up of 105 Months (ID 4454)
16:00 - 17:30 | Author(s): K. Yamada
The objective of this study is to confirm limited resection efficacy as radical surgery in patients with minimally invasive lung cancer as indicated by high-resolution (HR) computed tomography (CT), and to confirm intraoperative cytology as a negative margin indicator and reliable margin non-recurrence predictor.
Enrollment required patients with a tumor ≤ 2 cm in diameter, diagnosed or suspected as a clinical T1N0M0 carcinoma in the lung periphery based on a CT scan. They had to have a HRCT scan indicating a sub-solid nodule with tumor disappearance ratio; TDR ≥ 0.5. (TDR = 1- DM/DL; DM: maximum tumor diameter on mediastinal settings, DL: maximum tumor diameter on lung settings). Patients unfit for lobectomy and systematic lymph node dissection were excluded. We performed a wedge or segmental resection. The used stapling cartridges were washed with saline, which was cytologically evaluated. If cytology was cancer positive, additional margin was resected, and cytologic examination repeated. If the second exam was positive, a routine lobectomy and systematic lymph node dissection was performed. We aimed at enrolling 100 patients. The primary endpoint is 10-year local recurrence free survival rate.
This prospective study started in November 2003, and 101 patients were enrolled in 6 years. Of them, 99 were eligible for analysis. The mean age was 62 years (range: 30-75), and 60 were women. There were 11 Noguchi type A tumors, 54 type B tumors, 26 type C tumors, one type D tumor, one malignant lymphoma, 3 hyperplastic lesions, and 3 inflammatory fibroses. None of the 93 malignant nodules showed any vessel invasion. Although no positive cytology results were obtained, pathologically positive margin was reported after surgery in one type C patient. He later underwent a routine lobectomy and systematic lymph node dissection. There was no clear correlation between tumor size, TDR, and Noguchi subtype. No mortality occurred, but one patient developed postoperative pneumothorax and pneumonia, and another hemorrhagic gastric ulcer. With a median follow-up period of 105 months (range: 72−129) as of June 2016, there have been no recurrences, but one patient died for unspecified cause.
We have repeatedly warned that delayed cut-end recurrence is possible following limited resection even for small sub-solid lung cancers. So far, however, HRCT scans appear to predict non- or minimally invasive sub-solid lung cancers with high reliability, warranting limited resection as curative surgery in this cohort. Intraoperative cytology reliably indicated negative margins and seems to predict freedom from local recurrence.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
P3.02b-039 - Analysis of Prognostic Factor for Afatinib Treated Patients with EGFR Mutation Positive NSCLC (ID 6360)
14:30 - 15:45 | Author(s): K. Yamada
Afatinib, known as irreversible EGFR-TKI, significantly improved PFS and OS versus cisplatin-based chemotherapy, in combined analysis of LUX-Lung 3 and 6 despite this was not proved in treatment with former reversible agents. We have tried to examine the factors correlated to improvement of survival in patients treated with afatinib compared to gefitinib or erlotinib.
Patients who are enrolled in clinical trials from 2008 to 2014, and treated with EGFR-TKI as first line treatment were eligible. To explore the prognostic factors, we analyzed correlation of candidate factors including age, sex, clinical stage, mutation type and subsequent systemic treatments on medical record in afatinib treated group and reversible agents treated group including gefitinib or erlotinib.
Nineteen patients (5 men, 14 women) with a median age of 62 years (range, 46-88 ) were treated with EGFR-TKI as first line treatment. Twelve patients were treated with reversible TKIs, 8 with gefitinib, 4 with erlotinib. Seven patients were treated with afatinib. Median PFS for reversible TKI group versus afatinib group was 397 vs 422 days (P = 0.810). Median OS for reversible TKI group versus afatinib group was 741 vs 1380 days (P = 0.501). There is no difference between the two groups, age(P=0.147), sex(P=0.211), stage(P=0.891), and mutation type(P=0.581). Eleven patients received subsequent EGFR-TKI after first line EGFR-TKI failed as “re-challenge”, 7 patients in reversible TKI group, and 4 patients in afatinib group. There is no difference of tumor response of “re-challenge” EGFR-TKI, and duration of treatment with EGFR-TKI, in two groups.
The patient treated with afatinib tends to live longer in terms of overall survival. But there were no significant correlated factor between clinical characteristics and duration of survival.
P3.02b-124 - Efficacy of Osimertinib in Patients with Non-Small-Cell Lung Cancer (NSCLC) and Pleural Effusion (ID 5653)
14:30 - 15:45 | Author(s): K. Yamada
Although epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective in patients with mutated non-small-cell lung cancer (NSCLC), pleural or pericardial effusion is a known negative factor in EGFR-TKI monotherapy. Osimertinib, a 3rd-generation EGFR-TKI is an active agent for treating EGFR T790M-positive NSCLC. We analyzed the efficacy of osimertinib in EGFR T790M-positive patients with pleural effusion.
Patients treated with osimertinib were evaluated in clinical practice following approval of the drug in Japan. Treatment responses of tumor and effusion were measured and analyzed in patients with and without pleural effusion.
Twenty-five patients (7 men, 18 women) with a median age of 70 years (range, 38 – 86 years) were treated with osimertinib between 28 March and 30 June, 2016. Thirteen of the patients had no pleural effusion, of which twelve were evaluable for tumor response and all of these experienced efficacies in terms of response and stable disease. Twelve out of 25 patients had pleural effusion, of which ten patients were evaluable; of these, nine patients had no progression and one patient had progression during a short period of treatment with osimertinib. Regarding the pleural effusion in these ten patients, the effusion decreased in two patients and, was stable in three patients; in five patients, these was a slight or moderate increase despite daily administration of osimertinib. The long-term effects of treatment with osimertinib will be presented in detail at the meeting. Figure 1
Although an active agent in clinical practice, osimertinib might not provide an early response for pleural effusion.