Phase II randomized study of the IGF-1R pathway modulator AXL1717 compared to docetaxel in patients with previously treated, locally advanced or metastatic non-small cell lung cancer

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Phase II randomized study of the IGF-1R pathway modulator AXL1717 compared to docetaxel in patients with previously treated, locally advanced or metastatic non-small cell lung cancer

Bergqvist, Michael (author): Umeå universitet,Uppsala universitet,Centrum för klinisk forskning, Gävleborg,Institutionen för immunologi, genetik och patologi,Umea Univ, Dept Radiat Sci, Umea, Sweden,Institutionen för strålningsvetenskaper,Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden; Gävle Hospital, Center for Research & Development, Uppsala University/County Council of Gävleborg, Gävle, Sweden

Holgersson, Georg (author): Uppsala universitet,Experimentell och klinisk onkologi,Centrum för klinisk forskning, Gävleborg

Bondarenko, Igor (author)

Grechanaya, Elena (author)

Maximovich, Alexey (author)

Andor, György (author)

Klockare, Maria (author)

Thureson, Marcus (author)

Jerling, Markus (author)

Harmenberg, Johan (author)

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(creator_code:org_t)

2017
2017
English.
In: Acta Oncologica. - 0284-186X .- 1651-226X. ; 53:3, s. 441-447

Related links:: https://urn.kb.se/re...; show more...; https://doi.org/10.1...; https://urn.kb.se/re...; http://kipublication...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

BACKGROUND: The primary objective of this study was to compare the progression-free survival (PFS) at 12 weeks between patients treated with IGF-1R pathway modulator AXL1717 (AXL) and patients treated with docetaxel (DCT).MATERIAL AND METHODS: The study was conducted at 19 study centers in five countries. A total of 99 patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) of the squamous cell carcinoma (SCC) or adenocarcinoma (AC) subtypes in need of additional treatment were randomized and treated with either 300 or 400 mg of AXL as daily BID treatment (58 patients) or DCT given as 75 mg/m(2) in three-week cycles (41 patients) as monotherapy in a 3:2 ratio for each NSCLC subtype. Patients were treated in the primary study treatment period for a maximum of four treatment cycles.RESULTS: The 12-week PFS rate, median PFS and overall survival (OS), as well Kaplan-Meier hazard ratio for PFS and OS, did not show any statistically significant differences between the treatment groups. For the primary endpoint, the AXL group had a lower percentage of patients (25.9%) who were progression-free at Week 12 as compared to the DCT group (39.0%), although the difference was not statistically significant. The most notable difference in the incidence of treatment emergent adverse effects (TEAEs) was the lower incidence of treatment-related grade 3/4 neutropenia in patients treated with AXL.CONCLUSION: These results suggest neither of the treatments to be superior of the other when treating locally advanced or metastatic NSCLC. Considering the lower incidence of grade 3/4 neutropenia in the AXL group this treatment warrants further research.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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By the author/editor: Bergqvist, Micha ...; Holgersson, Geor ...; Bondarenko, Igor; Grechanaya, Elen ...; Maximovich, Alex ...; Andor, György; show more...; Klockare, Maria; Thureson, Marcus; Jerling, Markus; Harmenberg, Joha ...; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cancer and Oncol ...

Articles in the publication: Acta Oncologica

By the university: Uppsala University; Umeå University; Karolinska Institutet

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