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OncoTargets and Therapy Volume 10, 2017 - Issue
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Original Research

Impact of prior therapies on everolimus activity: an exploratory analysis of RADIANT-4

Roberto Buzzoni1 IRCCS Foundation, National Institute of Tumors, Milan, ItalyCorrespondence[email protected]
,
Carlo Carnaghi2 Humanitas Clinical and Research Center, Rozzano, Italy
,
Jonathan Strosberg3 Moffitt Cancer Center, Tampa, FL, USA
,
Nicola Fazio4 European Institute of Oncology, Milan, Italy
,
Simron Singh5 Sunnybrook Health Sciences Centre, Toronto, ON, Canada
,
Fabian Herbst6 Novartis AG, Basel, Switzerland
,
Antonia Ridolfi7 Novartis Pharma S.A.S., Rueil-Malmaison, France
,
Marianne E Pavel8 Medizinische Klinik 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
,
Edward M Wolin9 Montefiore Einstein Center for Cancer Care, Bronx, NY, USA
,
Juan W Valle10 Institute of Cancer Sciences, University of Manchester, The Christie Hospital, Manchester, UK
,
Do-Youn Oh11 Seoul National University Hospital, Seoul, Republic of Korea
,
James C Yao12 University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
&
Rodney Pommier13 Oregon Health & Science University, Portland, OR, USA
 show all
Pages 5013-5030 | Published online: 16 Oct 2017

Figures & data

Table 1 Patient demographics and baseline characteristics by prior therapies use

Table 2 Prior SSA exposure by study treatment (full analysis set)

Figure 1 Progression-free survival by central review (full analysis set).

Notes: Kaplan–Meier curves are shown for progression-free survival as assessed by central radiology review for both treatment arms (everolimus and placebo) in the patients who received (A) prior SSA, (B) no prior SSA, (C) prior chemotherapy, (D) no prior chemotherapy, (E) prior radiotherapy, and (F) no prior radiotherapy. The HRs in subgroups are obtained from unstratified Cox proportional hazards model.
Abbreviations: CI, confidence interval; HR, hazard ratio; SSA, somatostatin analogs.
Figure 1 Progression-free survival by central review (full analysis set).

Table 3 Progression-free survival by central review (full analysis set)

Table 4 Progression-free survival and best overall response (central review) of everolimus in different lines of treatment

Figure 2 Percentage change from baseline in size of target lesion, central review (full analysis set).

Notes: The plot shows the best percentage change from baseline in the size of the target lesion (ie, the best response in each patient) in the everolimus arm (left) and placebo arm (right) in the patients who received (A) prior SSA, (B) no prior SSA, (C) prior chemotherapy, (D) no prior chemotherapy, (E) prior radiotherapy, and (F) no prior radiotherapy.
Abbreviations: PD, progressive disease; SSA, somatostatin analogs.
Figure 2 Percentage change from baseline in size of target lesion, central review (full analysis set).
Figure 2 Percentage change from baseline in size of target lesion, central review (full analysis set).

Table 5 Best overall response by central review

Table 6 Drug-related adverse events reported by ≥10% of the patients

Table 7 Drug-related adverse events reported by ≥10% of the patients with respect to prior PRRT

Table S1 List of independent ethics committees (IECs) or institutional review boards (IRBs) by study center

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