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L. Livi
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-006 - Treatment beyond Progression in Patients with Advanced Squamous NSCLC Participating in the Expanded Access Programme (EAP) (ID 5450)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
Response patterns of immunotherapies differ from those seen with other therapies approved for the treatment of tumors. Due to this reason, immunotherapy protocols generally allow patients (pts) to continue treatment beyond investigator-assessed radiographic progressive disease (PD) as long as there is ongoing clinical benefit, but to date no data has been reported regarding treatment beyond PD in routine clinical practice. Here we report the analysis about the subgroup of pts treated beyond initial PD in the italian cohort of nivolumab EAP for pts with squamous non small cell lung cancer (Sq-NSCLC).
Methods:
Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events. Patients were allowed to continue treatment beyond initial PD as long as they met the following criteria: investigator-assessed clinical benefit, absence of rapid PD, tolerance of program drug, stable performance status and no delay of an imminent intervention to prevent serious complications of PD.
Results:
With a median follow-up of 5.2 months (range 0-12.9), 363 pts were evaluable for response. Prior to first progression, the objective response rate (ORR) was 14%, with 1 complete response (CR) and 50 (14%) partial responses (PR), and the disease control rate (DCR) was 41%. Sixty-six pts were treated beyond RECIST defined progression, with 23 pts obtaining a non-conventional benefit, meaning a subsequent tumor reduction or stabilization in tumor lesions. In particular, 17 pts obtained a SD and 6 pts obtained a PR. As to July 2016, median overall survival in these pts had not been reached (95% CI: 3.2-4.6) and 6 months and 12 months OS were 75% and 53%, respectively. The safety profile was consistent to what already observed in the general population.
Conclusion:
As already observed in clinical trials, these preliminary EAP data seem to confirm that a proportion of pts who continued treatment beyond PD demonstrated sustained reduction or stabilization of tumor burden, with an acceptable safety profile. Further investigations are warranted in order to better define and identify pts who can benefit from treatment beyond progression.
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-020 - Pattern of Care of Inoperable Locally Advanced (LA) NSCLC in Elderly Patients: Analysis of the Experience of Two Academic Italian Hospitals (ID 6038)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
Optimal treatment in LA NSCLC patients is still debated. In fit patients concomitant radio-chemotherapy (RCT) seems to be the best treatment in terms of local control (LC), progression free survival (PFS) and overall survival (OS) while sequential RCT is a good alternative in unfit patients. Moderately hypofractionated radiotherapy improve OS in recent studies. Elderly patients often cannot be offered multimodality treatments. We report our experience with over 70 years old LA NSCLC patients deemed unfit for surgery.
Methods:
Characteristics of patients and treatments are summarized in table 1. All patients were treated with a platinum based doublet of chemotherapy (CT). RT target volumes included the primary lung tumor and involved mediastinal lymphnodes as defined on pre-treatment contrast enhanced CT scan. Elective nodal irradiation was not performed. Acute/late toxicities were reported in accordance to 4.0 CTCAE scale. Clinical response was evaluated according to RECIST criteria.Patients' Characteristics Age Median 75 Range 70-83 Gender Male 50 (70%) Female 21 (30%) Performance Status (ECOG) 0 29 (41%) 1 36 (51%) 2 6 (8%) Histology Adenocarcinoma 31 (44%) Squamous Cell Carcinoma 39 (55%) Large Cell Carcinoma 1 (1%) Stage IIa/IIb 12 (17%) IIIa 39 (55%) IIIb 20 (28%) Chemotherapy Concomitant 9 (13%) Sequential 62 (87%) Cycles: median 4 Cycles: range 1-8 Radiotherapy Median Dose 62,3 Gy Moderate hypofractionation 26 (37%) Conventional fractionation 45 (63%)
Results:
At a median follow up of 10 months clinical response was evaluable in 69/71 patients obtaining a partial response in 35 of them, stable disease in 17, progressive disease in 17 patients. Twenty six patients experienced a local relapse within RT primary tumor volume, while 13 on nodal volume (5 patients both tumor and nodal relapse). 22 patients developed metastatic disease. One and 3-year OS was 62.3%(SE±6.2%) and 24,5%(SE±7.8%) respectively, while 1- and 3 year PFS was 45.1%(SE±6.9%) and 9,7%(SE±5.7%) respectively. At univariate analysis, tumor dimension (p<0,002) was the only prognostic factor statistically significant for OS. G1-G2 acute toxicity was observed in 45 patients: 36/62 in sequential CRT (3/36 developed also chronic toxicities) and 9/9 in concomitant CRT; most events were G1 oesophagitis (27 patients) and G1 cough (17 patients). No G3-4 event was reported.
Conclusion:
CRT is feasible in elderly patients; multidisciplinary evaluation is needed in order to reserve CRT to very fit patients.
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P2.04 - Poster Session with Presenters Present (ID 466)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.04-021 - Role of Adjuvant Radiotherapy and Prognostic Factor Analysis in Thymic Malignancies: A Retrospective Analysis of 129 Consecutive Patients (ID 5004)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
To evaluate the impact of histological subtypes, stage and therapeutic approaches on outcomes of a retrospective consecutive series of patients (pts) treated in 2 different Radiation Oncology Italian Centers
Methods:
One-hundred twenty nine pts were treated between 1982 and 2012.Sixty-six pts were male,63female;mean age was 58 years.The series was reclassified according to WHO 2004 staging:42 pts had epithelial/ mixed thymoma(type A/AB),72pts had cortical/medullary/atypical thymoma(B1/B2/B3) and 15 thymic carcinoma(type C).All pts were also staged using Masaoka classification(MKc) resulting in 43pts in stage I,30 stage IIA,13 stage IIB,24 stage III and 19 stage IVA.Radical surgery(thymectomy +/- mediastinal nodes sampling)was performed in all pts,30 of whom had positive margins,while 80 were also submitted to adjuvant thoracic RT(ART)due to their final pathological stage and/or surgical margins status. All pts were evaluated for clinical outcomes(overall survival-OS,progression free survival-PFS and local control-LC) and secondary malignancies incidence.
Results:
After a median follow up of 9.6 years,at time of analysis 103 pts were alive with a 5- and 10 year OS of 90.1%(SE±2,7)and 81.7(SE±3.7) respectively and a PFS of 84.8(SE±3.2) and 77.3(SE±4.0). Finally,5- and 10-year LC were respectively 94,1% (SE±2,2) and 89.2%(SE±3.2).In terms of OS, MKc advanced stage was found as a negative prognostic factors(p<0.0001) such as Performance Status (PS) with a p<0.0001, Tstage (p< 0,0001), aggressive histology (p=0.0001) and surgical positive margins (p< 0,0001) at univariate analysis. Regarding PFS,advanced MK stage,T stage, positive surgical margins and aggressive histology were confirmed as negative prognostic factor (p< 0,0001, p<0,0001, p<0,01, p<0,0001). Using Cox regression analysis ART seems to have a protective effect if stratified by MKc clinical stage (p< 0,03) just in terms of OS.Concerning local recurrence, a significant difference was found by T stage(p<0,001), surgical margins (p<0,03) and WHO classification(p=0.0001). At multivariate analysis PS, Surgical Margins and histology were statistically significant (p<0.0001, p<0.002 and p<0,001 respectively) with a negative impact on OS for PS>1, positive margins and thymic carcinoma differentiation. At the same analysis only thymic carcinoma differentiation influenced PFS when compared with PS, T and MKc stage, surgical margins and ART. During follow up secondary/methacronous neoplasms were diagnosed in 29 pts (22.5%)
Conclusion:
PS, surgical margins and WHO classification seems to be the most important indicators for long term survival. ART showed positive impact in terms of OS in advanced MKc clinical stage (Stage II-III) pts.
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P2.05 - Poster Session with Presenters Present (ID 463)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.05-019 - Stereotactic Body Radiotherapy (SBRT) for Central Lung Tumors: The Experience of Florence University-Careggi Hospital Radiotherapy (ID 6047)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
Stereotactic body radiotherapy (SBRT) for central lung tumors, defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumors immediately adjacent to the mediastinal or pericardial pleura (Adebahr S. et al. BJR 2015) is debated because of toxicities to organs at risk. No evidences from phase III trial are available.
Methods:
From 2010 to 2015, 45 central lesions in 40 pts were treated with SBRT. 14 lesions were primary lung cancer (PLC), 31 were lymphoadenopathies (LAP). PLC were treated with volumetric arc Therapy (VMAT) in 9 cases and 5 with Cyberknife®. LAP were treated with VMAT in 12 cases, with IMRT (step and shoot) in 10 and with Cyberknife® in 9 cases. Prescribed doses varied between 18 and 60 Gy (1-8 fractions) with median BED of 65 Gy (37,5-105 Gy). We evaluated Overall Survival (OS), Progression Free Survival (PFS) and Disease Specific Survival (DSS) using Kaplan-Meier method and treatment related toxicities using CTCAE version 4.0.
Results:
Median age was 62 years (48-86), 26 male and 14 female. PS was 0 in 9 pts, 1 in 21, 2 in 10 pts. Histology was available in all series and consisted of primary NSCLC (32 adenocarcinoma, 12 squamous cell carcinomas, 1 neuroendocrine tumour). 41 PLC were less than 2 cm from proximal bronchial tree, 4 PLC were immediately adjacent to the mediastinal or pericardial pleura. Tumor diameter was 10 to 60 mm with a median of 31 mm. Median follow up was 14,5 months. OS and DSS were 86.5% at 1 year, 55.6% at 2 years, and 49,4% at 3 years. PFS was 48,6% at 1 year, 24,1% at 2 years, and 12% at 3 years. 35 pts showed no acute toxicity; in 5 pts we recorded grade 1-2 esophagitis, in 2 pts grade 2 cough, in 2 pts, grade 1 asthenia. Chronic toxicity was present in 2 pts as grade 2 esophagitis.
Conclusion:
SBRT is confirmed to be a safe and effective strategy for central lung tumors. The majority of patients in the first part of our series was treated with low doses compared to current doses. Nevertheless 23 patients had clinical benefit from the treatment without life-threatening toxicities. Further studies are needed to establish the efficacy and safety of SBRT in central lung lesions.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-096 - Use of Nivolumab in Elderly Patients with Advanced Squamous NSCLC: Results from the Italian Expanded Access Programme (EAP) (ID 5706)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
The efficacy and safety of nivolumab in patients with squamous NSCLC (sq-NSCLC) have been demonstrated in several trials including the phase 3, randomized, controlled CheckMate 017 study whose results led to the approval of the product for this indication. However, data on the use of nivolumab in the real world setting is still limited and collecting it is paramount. The Italian nivolumab EAP for sq-NSCLC represents an important source of information in that respect. The current analysis describes results of the use of nivolumab in the group of EAP patients aged >75 years.
Methods:
Nivolumab was provided upon physicians’ request for patients aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Patients included in the analysis received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.
Results:
70 out of 372 (18.8%) patients with advanced Sq-NSCLC participating in the EAP in Italy were ≥75 years old and 68 of them were evaluable for response. With a median number of doses of 7 (range, 1–20) and a median follow-up of 4.7 months, the disease control rate was 42.9%, including 13 patients with a partial response and 17 with stable disease. 16 pts were treated beyond RECIST-defined progression and 5 of them achieved disease control. As of April 2016, the median progression-free survival and median overall survival among those elderly patients were 3.2 and 7.6 months, respectively. Among 70 pts, 41 pts (58.6%) discontinued treatment for any reason except toxicity; 8 out of 70 discontinued due to AE (11.4%).
Conclusion:
This analysis, conducted on elderly patients with sq-NSCLC in a real life setting, suggests that nivolumab is an effective and well tolerated treatment for this special population.
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P3.03 - Poster Session with Presenters Present (ID 473)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.03-029 - EPP Followed by Hemithoracic IMRT - A Multicenter Study on Behalf of the Italian Association for Radiation Oncology Lung Cancer Study Group (ID 4684)
14:30 - 15:45 | Author(s): L. Livi
- Abstract
Background:
The treatment of MPM is not well defined. Although it has been shown that extrapleural pneumonectomy (EPP) followed by hemithoracic RT may improve survival in early-stage disease, this therapeutic approach is declining. This might be due to the recent publication of a randomized trial (SAKK 17/04) which assessed the effect of high-dose hemithoracic RT after EPP. The study reported poor outcomes and the results did not support the use of hemithoracic RT. The major weakness of the SAKK study is the heterogeneity of the radiation techniques and schedules, and that only 12 patients received IMRT. On this background we conducted the present study to assess the outcome of MPM patients treated with EPP and adjuvant IMRT.
Methods:
This is a retrospective multicenter study, including 5 academic centers in Italy. Seventy patients treated with EPP and adjuvant IMRT were enrolled. The majority (95%) of patients had an epithelioid histology. Sixty patients were affected by stage III-IVA disease. Fifty-four (77%) patients received neoadjuvant/adjuvant chemotherapy. The IMRT dose ranged between 50-60 Gy in 25-27 fractions. Radiation was interrupted in two patients due to systemic progression of disease.
Results:
Median follow-up was 14 months (range, 0-83 months). Rates of local control, loco-regional control, distant-metastases free survival (DMFS) and overall survival (OS) at 2 years were 73%, 63%, 39%, and 63%, respectively. Patients with stage I-II had a better 2-year OS and DMFS than those with advanced disease: 60% vs. 40% (p=0.09), and 78% vs. 32% (p=0.03), respectively. Three fatal pneumonitis were reported. Other major toxicities were: Grade 2-3 pneumonitis in 2 cases, 1 bronchial fistula, and 1 Grade 3 esophagitis.
Conclusion:
This multicenter study showed that EPP followed by hemithoracic IMRT is associated with high rate of local and loco-regional control, and showed that long-term survival can be achieved, even if some patients may experienced life-threatening lung toxicity. Distant metastasis represent the predominant pattern of failure.
