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D. Cortinovis
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ORAL 27 - Care (ID 123)
- Event: WCLC 2015
- Type: Oral Session
- Track: Advocacy
- Presentations: 1
- Moderators:M.N. Mountain, J. Freeman-Daily
- Coordinates: 9/08/2015, 10:45 - 12:15, 708+710+712
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ORAL27.02 - Patients' Attitudes and Physicians' Perceptions Toward Maintenance Therapy for Advanced NSCLC: A Multicenter Italian Survey (ID 1448)
10:56 - 11:07 | Author(s): D. Cortinovis
- Abstract
- Presentation
Background:
Pemetrexed maintenance therapy (MT) after induction with platinum-based chemotherapy plus pemetrexed has recently become a concrete strategy of treatment for advanced non-squamous NSCLC patients, by extending survival, delaying disease progression, and maintaining quality of life. However, the benefit of the MT has to be weighed against the potential burden of a long-term treatment, and thus patients’ perception and preferences should be taken into account in the definition of the strategy of treatment.
Methods:
After conducting a focus group with 8 physicians dealing with NSCLC and concerning their opinions about the MT from a clinical and emotional point of view, a 12 questions-anonymous survey has been carried out in 13 Italian Oncologic Institutions and supported by WALCE (Women Against Lung Cancer in Europe), with the aim to evaluate patients' attitude toward the MT, the benefit they expected and to provide data about physicians awareness about patients’ inclinations. The Distress Thermometer Questionnaire has also been employed to perform a bio-psycho-social-spiritual assessment of the evaluated patients. Patients' evaluations have been performed at the beginning of chemotherapy (T0) and at the beginning of MT (T1), while physicians fill the survey only once during the study.
Results:
The survey has been prospectively (1st of December 2014-28th of February-2015) administered to 92 newly diagnosed advanced non-squamous NSCLC patients (58,7% male, median age 63,9 years), EGFR wilde-type, consecutively enrolled and suitable for first-line platinum/pemetrexed-based chemotherapy, and to 37 referring physicians (equally distributed per gender, with median age 41 years). To date, after platinum-based induction chemotherapy (median number of cycles 3,3, equally distributed between cisplatin and carboplatin), 24 of 92 patients enrolled (26,1%) have already started the pemetrexed MT. Main results are shown in Table 1. Most of the patients (73,9%) are in favor of MT. Until life expectation is over 3 months, data show agreement between patients' and physicians' perceptions of patients. When OS benefit drops at 1 month the two perceptions split: a lower percentage of patients (44,5%) would perform MT. By contrast, even without OS benefit, 71,3% of patients accept MT if it can increase symptom control. Figure 1
Conclusion:
Study is ongoing and data about T1 evaluations are still immature. Our preliminary data suggest the importance, when MT communication is done by the referral physician, to stress more symptoms control rather than survival rates.
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P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.08-005 - Vinorelbine as Second or Third-Line Therapy in Pemetrexed-Pretreated Malignant Pleural Mesothelioma (MPM) Patients (ID 2403)
09:30 - 09:30 | Author(s): D. Cortinovis
- Abstract
Background:
There is no standard treatment for patients (pts) with MPM progressing during or after pemetrexed/platinum-based chemotherapy (PBC). Single agent chemotherapy is often administered in everyday practice, although its use is poorly supported by clinical trials. The aim of this retrospective study (NCI01865045) was to analyze the efficacy and toxicity of second (2nd) and third (3rd) line vinorelbine (VNR) in a large cohort of PBC-pretreated MPM patients.
Methods:
The clinical records of MPM pts consecutively treated in 8 Italian Centers with intravenous (iv) or oral (po) VNR as 2nd or 3rd line treatment following PBC were reviewed. Radiological response was assessed by modified RECIST criteria. Toxicity was reported according to CTCAEv4 criteria. Relative dose-intensity (DI) of VNR was calculated. Progression-free survival (PFS) and overall survival (OS) were estimated and correlated to clinical variables: age, gender, histological subtype, ECOG performance status (PS), line of VNR therapy (2nd vs 3rd) and outcome of first-line treatment.
Results:
From August 2001 to September 2014, 161 pts (M/F 120/41) were treated, 128 with iv and 33 with po VNR. Most of the cases included (92%) were treated after 2007. Histological subtype was epithelioid in 134, biphasic in 15, sarcomatoid in 8 and unspecified in 4 pts. Median age was 67 years (range 41-82). VNR was administered as 2nd or 3rd line treatment in 94 and 67 pts, respectively. Median number of VNR cycles was 3 (range 1-26), median relative DI was 88%. Main grade 3-4 toxicities were neutropenia in 9%, fatigue in 4% and constipation in 5% of pts. No toxic death occurred. A partial response was observed in 10 pts (6%), stable disease in 57 (35%), for an overall disease control rate of 41%. Median PFS and OS were 2.5 and 6.7 months, respectively. In multivariate analysis, only ECOG PS (0 vs 1-2) was significantly associated with improved PFS and OS. An analysis of molecular predictors of VNR response is ongoing.
Conclusion:
In this large retrospective patient cohort, 2nd and 3rd line VNR had modest but definite activity in PBC-pretreated MPM patients, with an excellent toxicity profile. Although inclusion in prospective clinical trials of new agents should be always considered in this setting, single agent VNR remains a reasonable option for palliation.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-082 - Multicenter Randomized Trial Comparing Erlotinib vs. Gemcitabine or Vinorelbine as Third-Line in Advanced EGFR-Wild-Type or Unknown NSCLC (ID 651)
09:30 - 09:30 | Author(s): D. Cortinovis
- Abstract
Background:
In clinical practice, approximately one third of patients with advanced non-small cell lung cancer (NSCLC) is candidate at third-line treatment. Currently, only erlotinib is licensed with this indication. Recent studies (TAILOR and DELTA trials) have questioned the role of erlotinib in second-line therapy of patients with advanced EGFR wild-type NSCLC, suggesting an inferiority in survival compared to chemotherapy with docetaxel. For this reason, the use of erlotinib is gradually shifting to the third-line. However, in this setting, chemotherapy drugs, such as gemcitabine or vinorelbine, could achieve similar survival results, with limited toxicity and lower costs than erlotinib. Therefore, the objective of this study is to evaluate the efficacy of chemotherapy (gemcitabine or vinorelbine) vs. erlotinib in the treatment of patients with advanced EGFR wild-type or unknown NSCLC progressing after two lines of chemotherapy in terms of overall survival (primary end-point). The treatments will be also compared in terms of activity, quality of life, toxicity and costs (secondary end-points).
Methods:
538 patients will be enrolled from 40 clinical Italian centers and assigned by randomization to one of 2 treatment arms (chemotherapy vs. erlotinib) with a ratio of 1:1. As stratification factors will be considered: the center, histology (squamous vs. non-squamous), EGFR (wild type vs. unknown) and PS (0-1 vs. 2). Patients will be randomized to receive treatment with erlotinib 150 mg/day (control arm) or chemotherapy with gemcitabine 1000 mg/m[2] or vinorelbine 25 mg/m[2] on days 1, 8 every 21 days (experimental arm), according to investigator choice and previous treatment received. Treatments will be administered until disease progression, patient refusal, unacceptable toxicity, patient clinical deterioration or investigator decision. It was estimated that with 440 deaths from any cause the study would have 85% power to detect a hazard ratio of 0.75 at a two-sided significance level of 5%. If the superiority comparison will fail to detect a significant difference between treatments, the non-inferiority of the chemotherapy arm will be tested with a power equal to 65% against a prospectively defined margin for non-inferiority of the HR equal to 1.25.
Results:
not applicable
Conclusion:
If this study should be positive, it will follow a change in clinical practice with an improvement in life expectancy of patients with advanced NSCLC and savings in terms of economic resources for the NHS. This study (CONFERMER trial) is supported by NHS, Regione Emila Romagna. As to 14 April 2015, 44 patients were randomized.
