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T. Niwa
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-001 - Serum Albumin Level Predicts the Survival Benefit of Chemotherapy in Elderly Advanced NSCLC Patients with Poor Performance Status (ID 7326)
09:00 - 09:00 | Author(s): T. Niwa
- Abstract
Background:
There have been few data on the chemotherapy in elderly advanced non-small cell lung cancer (NSCLC) patients with poor performance status (PS), and usefulness of chemotherapy for such patients remains unclear.
Method:
All consecutive patients with advanced NSCLC, elerly (≥75 years old), ECOG PS ≥2, EGFR mutation negative/unknown, and newly diagnosed from January 2009 to December 2012 at Kurashiki Central Hospital, were retrospectively reviewed to clarify the factors which predicts the survival benefit of chemotherapy.
Result:
59 patients were enrolled. 31 patients received at least one chemotherapy regimen (chemotherapy group), whereas 28 patients received best supportive care (BSC) alone (BSC group). The proportion of PS 2 and serum albumin level were significantly higher in the chemotherapy group than in the BSC group. The overall survival (OS) was longer in the chemotherapy group than in the BSC group (median OS of 4.7 months and 3.1 months, p = 0.0119). In the chemotherapy group, log-rank testing did not show statistically significant differences in OS between single-agent therapy group and carboplatin-based doublet therapy group, whereas the OS of the patients who received chemotherapy for only 1 cycle was significantly better than those of the patients who received chemotherapy for ≥ 2 cycles. Hypoalbuminemia was not only the risk factor for the early termination of chemotherapy, but also the independent prognostic factor in the chemotherapy group. A receiver operating characteristic curve analysis showed that the best cut-off value was 3.40 g/dl. In the patients with serum albumin ≥ 3.40 g/dl, OS was significantly longer in chemotherapy group than that in BSC group (p=0.0156), whereas, the patients with serum albumin < 3.40 g/dl exhibited poor prognosis regardless of presence/absence of chemotherapy. Figure 1
Conclusion:
In the elderly advanced NSCLC patients with poor PS, serum albumin level may help identify the patients who are more likely to benefit from chemotherapy.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-008 - Phase I/II Study of Intermitted Erlotinib in Combination with Docetaxel in Patients with Recurrent NSCLC with Wild-Type EGFR: WJOG 4708L (ID 7556)
09:30 - 09:30 | Author(s): T. Niwa
- Abstract
Background:
Erlotinib (ERL) is modestly active to non-small cell lung cancer (NSCLC) with wild type epidermal growth factor receptor (EGFR). We hypothesized that an intermittent delivery of erlotinib and docetaxel (DOC) would increase efficacy.
Method:
This was a multi-center, single-arm phase I/II study in patients with wild type EGFR NSCLC who failed one prior chemotherapy. The phase I was designed a standard 3+3 dose escalation design to determine feasibility, the maximum tolerated dose (MTD) and phase II recommend dose (RD) of ERL on days 2 to 16, in combination with a fixed dose of 60mg/m[2] DOC on day 1. The phase II primary endpoint was objective response rate (ORR) by independent review committee. This study required 41 patients with expected ORR of 30% and threshold ORR of 10% (one-sided α= 0.025; β=0.1). The target number was 45 patients assuming the loss of follow-up cases. All eligible patients had ECOG performance status of 0/1 and adequate organ functions.
Result:
Between Mar 2009 and Dec 2010, 12 patients were enrolled in the phase I, and between May 2011 and Feb 2015, 46 patients in the phase II. Five patients were excluded from per protocol set, because of deviation of entry criteria. Planned dose escalation was completed without reaching a MTD. The RD was determined as 150 mg/dose of ERL. In the phase II, the ORR was 17.1% (95%CI, 7.2-32.1). The median progression free survival and median overall survival were 3.48 months (95%CI, 3.06-4.50) and 11.27 months (95%CI, 8.61-16.56), respectively. Gender, smoking status, or concomitant drugs which influence the ERL metabolism had no significant differences in ORR, or disease control rate. All 46 patients were evaluable for toxicity. The grade 3 non-hematological toxicities included 9 (19.6%) febrile neutropenia, 7 (15.2%) appetite loss, 3 (6.5%) oral mucositis and 3 (6.5%) infections. The grade 4 hematological toxicities were 31 (67.4%) neutropenia. Two treatment related deaths were observed; interstitial lung disease, and pleural infection.
Conclusion:
Intermittent dosing of ERL plus DOC is clinically feasible, but has no statistically significant improvement of ORR, in patients with recurrent NSCLC with wild type EGFR.
