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G. Valmadre
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ORAL 04 - Adjuvant Therapy for Early Stage Lung Cancer (ID 99)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:E. Vallieres, Y. Ohe
- Coordinates: 9/07/2015, 10:45 - 12:15, 205+207
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ORAL04.03 - Preliminary Results of the International Tailored Chemotherapy Adjuvant Trial: The ITACA Trial (ID 1262)
11:07 - 11:18 | Author(s): G. Valmadre
- Abstract
Background:
In resected early stage (II-IIIA) non-small cell lung cancer (NSCLC) adjuvant chemotherapy improves overall survival but the benefit is limited and pharmacogenomics tailored treatment is a potential way to further improve outcome. A phase III multicenter randomized trial comparing adjuvant pharmacogenomics-driven chemotherapy, based on thymidylate synthase (TS) and excision-repair cross-complementing-1 (ERCC1) gene expression versus standard adjuvant chemotherapy in completely resected Stage II-IIIA NSCLC recently completed patients’ (pts) enrolment (EudraCT #: 2008-001764-36).
Methods:
The mRNA ERCC1 and TS expression by qRT-PCR was centrally assessed on paraffin-embedded, post-surgical tumor specimens in all registered pts. Immunohistochemistry (IHC) straining for ERCC1 (using 2 monoclonal antibodies, 8F1 and 4F9) and TS protein expression was also performed. Randomization was stratified by stage and smoking status. Trial was emended on February 2011 to include the 7th staging system. The primary end point of the study is overall survival; secondary end points include recurrence-free survival, therapeutic compliance, toxicity profile and comparative evaluation of ERCC1 and TS mRNA versus protein expression. Study design was already reported [Novello S et al, JTO 2013; 8 (Suppl 2) P3.12-023].
Results:
Enrolment was concluded in August 2014 and at that time all gene expression data were available. Recruitment and gene expression results were completed in August 2014. 386 pts were included in the control arm, 375 in the tailored arm and 41 were excluded as screening failures (14) or are not yet fully evaluable (27). Statistical correlations to compare treatments received, toxicity profiles and pts’ survival data in the tailored and control groups are ongoing. Further data analyses will include the correlation between biomarker ERCC1/TS mRNA and protein expression levels, as well as compare ERCC1-IHC scores with the 2 ERCC1 antibodies. The distribution of some baseline characteristics depending on the molecular profile is shown in Table 1. Figure 1
Conclusion:
This trial will provide robust evidence if a tailored therapeutic strategy based on selected gene expression profile may contribute to improve efficacy and to ameliorate toxicity of adjuvant chemotherapy in completely resected early stage NSCLC.
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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): G. Valmadre
- 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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P1.05 - Poster Session/ Prevention and Tobacco Control (ID 215)
- Event: WCLC 2015
- Type: Poster
- Track: Prevention and Tobacco Control
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.05-005 - Italian Multicentric Survey on Smoking Cessation in Lung Disease Patients and the Role of Healthcare Workers in This Contest (ID 1343)
09:30 - 09:30 | Author(s): G. Valmadre
- Abstract
Background:
Smoking is a risk factor for several lung diseases. Quitting smoking provides positive outcomes and gives the best chance for the treatment in patients with pulmonary diseases, including lung cancer diagnoses. Currently few centers in Italy offer counseling for smoking cessation in cancer patients (and for patients with other lung diseases), despite the demonstrated efficacy of it.
Methods:
408 patients with pulmonary diseases (72% with lung cancer) were prospectively and sequentially evaluated from January 2013 to February 2015. An anonymous survey was developed with the aim to understand if current or former smoker patients received information by healthcare workers about smoking cessation before or after the diagnosis, their reaction and the actions adopted for quitting smoking. The survey included the Fagerström test for assessing the intensity of addiction to nicotine and it was conducted in several Italian Thoracic Oncology Units and Pulmonology Divisions.
Results:
After a pulmonary disease diagnosis, 72% of patients state to quit smoking, 20% to smoke less or not feel the same pleasure as before and only 8% confirms to continue to smoke or smoking even more. Among former smokers (298 people), 150 patients state how long they quitted smoking and in 45% of the cases was at the time of diagnosis or even later, about 35% 10 years before the diagnosis and 8% between 5 and 10 years earlier, while 12% more recently. Most of current smokers state that they continue because smoking helps them to control the stress, others because they like it or are not able to quit and very few because is a repetitive gesture. Data show that 39% of patients did not receive information about smoking cessation by health professionals, 26% received it before the diagnosis, 12% after it and 23% received it both before and after the diagnosis. Concerning the reaction to the counseling, 53% considers positively the health care provider action, even if 28% hoped they could have helped them more quit smoking and 19% reports a warning and paternalistic attitude of them. Only 23% of patients who attempted to quit smoking considers the gradual termination as the most effective measure, more than the sudden interruption. Regarding the smoking-cessation method or specific therapy adopted, 65% disclosed they simply quitted smoking overnight and 80% confirmed it as the most effective technique, while only 16% used electronic cigarettes, 8% a nicotine replacement treatment, 7% books and 4% attending a dedicated clinic. The Fagerström Test confirms that 50% has a low to moderate dependence to nicotine, while 50% has a high dependence.
Conclusion:
The survey was distributed to 293 lung cancer patients and 115 with pulmonary disease (mainly COPD patients). The result analysis underlines that the vast majority quitted smoking after having received their diagnosis. No main differences were seen evaluating the group with malignant and non-malignant diseases. Although many of them got advice by healthcare workers, the recourse to the use of techniques, drugs or access to specific clinic is still very low, especially considering that 50% of patients result highly dependent to nicotine.
