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Alessandro Del Conte
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MA26 - New Therapies and Emerging Data in ALK, EGFR and ROS1 (ID 930)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 201 BD
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MA26.02 - Upfront or Sequential Strategy for New Generation Anaplastic Lymphoma Kinase (ALK) Inhibitors: An Italian Retrospective Study. (ID 12790)
13:35 - 13:40 | Author(s): Alessandro Del Conte
- Abstract
- Presentation
Background
Anaplastic lymphoma kinase (ALK) rearrangement confers sensitivity to ALK inhibitors (ALKis) in non-small-cell lung cancer (NSCLC). Although several drugs provided an impressive outcome benefit, the most effective sequential strategy is still unknown.
a9ded1e5ce5d75814730bb4caaf49419 Method
We retrospectively collected 242 ALK-positive advanced NSCLC diagnosed between 2010 and 2018 in 23 Italian institutions (expanded data collection from Gobbini et al. Lung Cancer 2017). 138 patients received exclusively crizotinib as ALKi (not considered for this analysis). 78 patients received crizotinib and a new (second or third) generation ALKis as further treatments (group A). 26 patients performed a new generation ALKi as upfront agent (group B). These groups are larger than those considered in a previous analysis (15 and 8 patients, respectively).
4c3880bb027f159e801041b1021e88e8 Result
Study population clinical features and treatments received are summarized in Table 1.
Group A
Crizotinib followed by new generation ALKis
N= 78
Group B
Upfront new generation ALKis
N=26
Treatments per line n(%)
1°
2°
3°
4°
1°
2°
3°
4°
Crizotinib
28(36)
50(64)
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-
-
-
2(8)
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Alectinib
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11(14)
18(23)
5(17)
7(27)
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Ceritinib
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9(12)
23(30)
3(4)
8(31)
8(31)
1(4)
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Brigatinib
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6(8)
6(8)
2(3)
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2(8)
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2(8)
Lorlatinib
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4(5)
5(6)
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1(4)
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Chemotherapy
50(64)
2(3)
10(13)
na
11(42)
6(23)
1(4)
Na
Clinical features n(%)
Age (range)
58 (27-83)
55 (24-82)
Male
37(47)
10(38)
p= 0.42
Female
41(53)
16(62)
Current smoker
8(10)
5(19)
p= 0.23
Never/former smoker
70(90)
21(81)
ALKi beyond PD
27(34)
4(15)
p= 0.06
With a median follow-up of 22.6 months (CI 95% 20.09-25.10), 33 patients had died (32%). In group B, the median progression free survival (PFS) for new generation ALKis administered as first (14.0 months, CI 95% 9.52-18.471), second (12.7 months, CI95% 7.22-18.17) or third-line (12.8 months, CI95% 6.24-19.35) was not statistically different (p= 0.522). The median time from the start of crizotinib to the disease progression after the new generation ALKi sequentially performed (group A) was longer than that one detected in group B for the upfront new generation ALKis (29 vs 14 months, HR 2.47 [CI95% 1.35-4.50], p=0.003). This result was confirmed even considering the time lost between the two treatments in group A. The median overall survival (OS) was not reached. The 12-months OS rate was 97% in group A and 84% in group B.
8eea62084ca7e541d918e823422bd82e Conclusion
New generation ALKis maintain their efficacy regardless of the treatment setting considered. The sequential strategy seems to provide a substantial benefit, but a longer follow-up and larger samples are needed to clarify the survival impact.
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-73 - Preliminary Results of the SENECA (SEcond Line NintEdanib in Non-Small Cell Lung CAncer) Trial: An Italian Experience. (ID 13281)
16:45 - 18:00 | Author(s): Alessandro Del Conte
- Abstract
Background
Nintedanib is a multi-target small-molecule with anti-angiogenetic activity which confers longer progression free survival (PFS) and overall survival (OS) as second-line combination treatment with docetaxel versus standard-of-care, in non-squamous non-small cell lung cancer (nsNSCLC) patients, giving to rapidly progressing patients the greatest survival benefit. Considering the higher tolerability of weekly docetaxel than docetaxel q3wks in the real-life, the SENECA trial, a phase IIb, open label, Italian multicentre study, aims to evaluate whether treatment with nintedanib and docetaxel could be effective and safe as second-line option in nsNSCLC patients with the two different schedules.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients from eighteen Italian oncologic centres, with stage IIIB/IV non-oncogene addicted nsNSCLC patients, progressing after first-line chemotherapy, have been treated with docetaxel (T1: 33 mg/mq on days 1 and 8 in a 21-days cycle; T2: 75 mg/mq q3wks) plus continuous oral nintedanib, with the possibility of maintenance in case of stabilization or response. Primary endpoint was PFS (by investigator’s assessment), while secondary endpoints included OS, safety and quality-of-life. Study stratifies patients into two cohorts according to relapse-timing (within or over 3 months) from end of first-line chemotherapy.
4c3880bb027f159e801041b1021e88e8 Result
From January 2016 to data cut-off, on 30th March 2018, 197 patients have been evaluated: 30 were registered as screening failures, mainly for contraindications to nintedanib use. The 167 patients considered in this preliminary analysis had a median age of 63.4 years (range 35-86), were predominantly male (68.9%), smokers or former-smokers (84.4%) and with ECOG-performance status 0 (72.5%). According to investigator’s choice, 82 patients have been treated with T1 docetaxel (49.1%), 85 (50.9%) with T2 docetaxel (median docetaxel treatment 3.5 and 3.7 21-days cycles, respectively). No significant differences in median PFS have been observed between T1 and T2 (3.83 vs 4.32 months, respectively; HR 0.889 [95% IC 0.598-1.321], p-value=0.559). After a median follow-up of 7.28 months (standard deviation=5.55), a trend of similar OS has emerged in both T1 and T2 (6.63 vs 7.91 months, respectively; HR 0.770 [95% IC 0.484-1.225], p-value=0.270). Survival data of relapse-timing cohorts are not yet mature. Commonest toxicities in T1 and T2 were: fatigue (53.6% vs 65.9%, respectively), diarrhea (50.0% vs 47.0%), afebrile neutropenia (13.4% vs 52.9%) and ALT elevation (29.3% vs 20.0%).
8eea62084ca7e541d918e823422bd82e Conclusion
The SENECA trial is a real-life Italian experience, whose preliminary results confirm the efficacy and safety of second-line treatment with nintedanib and docetaxel for nsNSCLC patients, regardless from docetaxel schedule, suggesting higher toxicities for docetaxel q3wks.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.09 - Pathology (Not CME Accredited Session) (ID 958)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.09-21 - Women with Synchronous or Metachronous Lung and Ovarian Cancers: A Multi-Institutional Report (ID 12485)
16:45 - 18:00 | Author(s): Alessandro Del Conte
- Abstract
Background
In women, lung cancer (LC) and ovarian cancer (OC) are, respectively, the second and eighth malignancies for incidence in developed Countries. Despite increasing incidence and mortality of LC, association with OC is rare and no literature data are available on this topic yet. Our aim was to describe a series of patients with synchronous or metachronous LC and OC and to identify common clinical and pathological patterns.
a9ded1e5ce5d75814730bb4caaf49419 Method
We retrieved the medical charts of patients who referred to 30 European Oncological Institutes from 2008 to 2018. When patients with synchronous (up to 3 months of time interval in onset) or metachronous LC and OC were found, we collected detailed medical history, pathological features and clinical outcomes. Whenever available, formalin fixed paraffin embedded tumor tissue from both specimens was collected for centralized pathology revision with an immunohistochemical marker panel including TTF-1 and PAX-8. In ambiguous cases, a broader panel was performed (p40, CK-7, WT1, CA125, Calretinin, EMA, CEA, CgA, Vimentin, Napsin-A). Whenever tested, genetic alterations in LC and OC were also reported.
4c3880bb027f159e801041b1021e88e8 Result
As of April 2018, among 30 European Oncological Centers (Italy, France, Slovenia), 11 retrieved in their series patients with a history of LC and OC, for a total of 18 cases in the last 10 years. Paired histological specimens were available in 6 cases. One patient was excluded, since pathology revision revealed that lung lesions were metastases from serous OC. Thus, analyses were performed on 17 patients. In 10/17 cases (58.8%), LC and OC were metachronous and, in 6/10 cases, OC preceded LC diagnosis, with a median interval of 4.5 years. Median age at diagnosis of the first malignancy was 62 years, the majority of patients (64.7%) were never-smoker, 6 had cancer familial history. Interestingly, 4 patients (23.5%) reported also a third or fourth malignancy. After a median follow-up of 6.5 years, 10 patients are alive. Regarding histology, most of LC were adenocarcinoma (14/17, 82.3%). Molecular status was available in 9/14 cases: 4 had EGFR mutation, 1 B-RAF mutation and 2 ALK translocation. OC were mostly high-grade serous (83,3%). BRCA status was available in 6 patients: 2 mutated, 2 wild-type and 2 affected by variants of unknown significance (USV). Moreover, one synchronous case presented both BRCA-USV and B-RAF mutation.
8eea62084ca7e541d918e823422bd82e Conclusion
In our series, synchronous and metachronous LC and OC were often driven by genetic alterations. Further genetic analysis with next generation sequencing technology has already been planned.
6f8b794f3246b0c1e1780bb4d4d5dc53
