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M. Papi
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MINI 10 - ALK and EGFR (ID 105)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:T. Yap, T. Li
- Coordinates: 9/07/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI10.01 - Frequency of Concomitant EGFR, EML4-ALK or KRAS Alterations in NSCLC Patients and Correlation with Response to Treatment (ID 942)
16:45 - 18:15 | Author(s): M. Papi
- Abstract
- Presentation
Background:
Epidermal growth factor receptor (EGFR) and KRAS mutations, and echinoderm microtubule-associated protein-like 4 (EML4) anaplastic lymphoma kinase (ALK) translocation are generally considered to be mutually exclusive. However, some reports show that a number of patients may have concomitant mutations, and it is not yet clear what impact these double mutations could have on response to targeted therapy.
Methods:
We took into consideration 380 NSCLC patients who underwent non-sequential testing for EGFR and KRAS mutations and EML4-ALK translocation between January 2010 and December 2013. EGFR mutation and EML4-ALK translocation analysis were performed on the entire case series and KRAS mutation analysis was performed on 282 cases.
Results:
EGFR mutation and EML4-ALK translocation were present in 44 (11.6%) and 32 (8.4%) of patients, respectively. Ninety-two patients (32.6%) showed a KRAS mutation. Two concomitant mutations among EGFR, KRAS or EML4-ALK genes were observed in 16 patients. In particular, 6 of the 380 (1.6%) patients analyzed had concomitant EGFR mutation and EML4-ALK translocation. Of the 282 patients who also underwent KRAS mutation, 3 (1.1%) showed a concomitant EGFR and KRAS mutation and 7 (2.5%) a concomitant EML4-ALK and KRAS alteration. Of the 44 EGFR-mutated patients, 28 received a TKI-based treatment (24 with gefitinib and 4 with erlotinib) as first-line therapy, and 6 of these also had an EML4-ALK translocation. Among the 22 patients with EGFR mutation only, we observed 2 complete response (CR) (9%), 16 partial response (PR) (72.7%) and 4 progressive disease (PD) (18%). Of the 6 patients who also had an EML4-ALK translocation, one had CR (17%), 3 PR (50%) and 2 PD (33%). No differences were seen in terms of overall survival (OS). Of the 32 patients harboring the EML4-ALK translocation, 6 (those also carrying the EGFR mutation) were treated with a TKI as first-line therapy, while the others received chemotherapy. Twelve patients received crizotinib as second-line treatment and 7 progressed within 3 months of starting therapy. Of these, 2 showed a concomitant KRAS mutation (G12C) and one a concomitant EGFR mutation (exon 19 del). Two patients had stable disease, one of whom also showed a KRAS mutation (G12V). Two patients had PR and one had CR, all of whom showed a EML4-ALK translocation only. The median OS of the patients carrying an EML4-ALK translocation alone or a concomitant KRAS mutation was 57.1 (range 10.7-nr) and 10.7 (range 4.6-nr) months, respectively.
Conclusion:
The concomitant presence of EGFR, EML4-ALK or KRAS mutations is a possible event in NSCLC. KRAS mutation in patients with EML4-ALK translocation represents the most common double mutation and seems to confer a poor prognosis.
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-011 - Maintenance with Lanreotide in SCLC Patients, Expressing Somatostatine Receptors, after Response to First Line Therapy (ID 2838)
09:30 - 17:00 | Author(s): M. Papi
- Abstract
Background:
Small cell lung cancer (SCLC) is a rapidly progressive disease, characterized by rapid progression in spite of initial responsiveness to first-line chemotherapy. In this setting, an effective and safe maintenance therapy might result in improved disease control; to date, no maintenance strategy has been registered for SCLC yet. Since SCLC cells express a neuroendocrine phenotype, some tumors may express significant levels of somatostatin (SST) receptors; this feature might be exploited for new therapeutic approaches. The aim of our study is to investigate the activity of lanreotide, a SST analogue, as maintenance for patients with SCLC who have achieved a complete response (CR) or partial response (PR) to standard platinum-based chemotherapy (CHT) alone or combined with radiation therapy (RT) , in order to improve progression-free survival (PFS).
Methods:
In this prospective, open-label, multicenter, randomized phase III trial, patients with confirmed diagnosis of SCLC (limited or extended disease) expressing SST receptors (assessed by SST receptor scintigraphy) and with objective response (CR or PR) after CHT or CHT/RT are randomized (1:1) to one of the following arms: maintenance therapy/consolidation with 120 mg lanreotide, by deep subcutaneous injection, every 28 days up to progressive disease (PD) or one year (Arm A); or observation (Arm B). The patients were re-assessed every two months until documented PD during the first year after randomization, and then every three months. The planned enrollment period is 24 months, followed by a period of maintenance of 12 months and further 6 months for the completion of follow-up; the planned global period of the study is 3 years and a half.
Results:
This study is still ongoing; therefore, it is not possible to show its final results yet.. However, relevant preliminary data can be described. Currently, out of 76 expected patients, 53 were enrolled; of these, 11 patients (37.96%) in Arm A had limited disease and 18 (62.06%) extended disease. In Arm B, 11 patients had limited disease (45.83%) and 13 (54.17%) had extended disease. After one year of follow-up, among 29 patients randomized to Arm A, 1 patient died (3.45%), while 12 patients experienced PD (41.38%), and 16 are still on study (55.17%); among 24 patients randomized to Arm B, 2 deaths occurred (8.33%), while 11 patients experienced PD (45.83%) and 11 are still on study (45.83%). In Arm A, no significant adverse events were reported.
Conclusion:
This study will determine whether maintenance with lanreotide could prolong PFS of patients with SCLC expressing SST receptors and responsive to upfront CHT or CHT/RT. Moreover, the final results of this study might establish if this treatment could result in an improved overall survival rate after two years. To date, lanreotide has demonstrated an excellent safety profile in all the treated patients. On behalf of FONICAP (Forza Operativa Nazionale Interdisciplinare contro il Cancro del Polmone)
