Research Papers:

Imatinib dose escalation versus sunitinib as a second line treatment in KIT exon 11 mutated GIST: a retrospective analysis

Bruno Vincenzi, Margherita Nannini, Elena Fumagalli, Giuseppe Bronte, Anna Maria Frezza, Delia De Lisi, Mariella Spalato Ceruso, Daniele Santini, Giuseppe Badalamenti, Maria Abbondanza Pantaleo, Antonio Russo _, Angelo Paolo Dei Tos, Paolo Casali and Giuseppe Tonini

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Oncotarget. 2016; 7:69412-69419. https://doi.org/10.18632/oncotarget.5136

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Bruno Vincenzi1, Margherita Nannini2, Elena Fumagalli3, Giuseppe Bronte4, Anna Maria Frezza1, Delia De Lisi1, Mariella Spalato Ceruso1, Daniele Santini1, Giuseppe Badalamenti4, Maria Abbondanza Pantaleo2, Antonio Russo4, Angelo Paolo Dei Tos5, Paolo Casali3, Giuseppe Tonini1

1Department of Oncology, University Campus Bio-Medico, Rome, Italy

2Department of Specialized, Experimental and Diagnostic Medicine, Sant’Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy

3Adult Mesenchymal Tumor Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

4Section of Medical Oncology, Department of Surgical, Oncological and Oral Sciences, University of Palermo, Palermo, Italy

5Department of Oncology and Pathology, General Hospital of Treviso, Treviso, Italy

Correspondence to:

Antonio Russo, e-mail: [email protected]

Bruno Vincenzi, e-mail: [email protected]

Keywords: imatinib, sunitinib, second line, GIST, exon 11

Received: July 03, 2015     Accepted: August 04, 2015     Published: September 26, 2015


We retrospectively reviewed data from 123 patients (KIT exon 11 mutated) who received sunitinib or dose-escalated imatinib as second line.

All patients progressed on imatinib (400 mg/die) and received a second line treatment with imatinib (800 mg/die) or sunitinib (50 mg/die 4 weeks on/2 off or 37.5 mg/day). Deletion versus other KIT 11 mutation was recorded, correlated with clinical benefits.

64% received imatinib, 36% sunitinib. KIT exon 11 mutation was available in 94 patients. With a median follow-up of 61 months, median time to progression (TTP) in patients receiving sunitinib and imatinib was 10 (95% CI 9.7–10.9) and 5 months (95% CI 3.6–6.7) respectively (P = 0.012). No difference was found in overall survival (OS) (P = 0.883). In imatinib arm, KIT exon 11 deletions was associated with a shorter TTP (7 vs 17 months; P = 0.02), with a trend in OS (54 vs 71 months P = 0.063). No difference was found in patients treated with sunitinib (P = 0.370).

A second line with sunitinib was associated with an improved TTP in KIT exon 11 mutated patients progressing on imatinib 400 mg/die. Deletions in exon 11 seemed to be correlated with worse outcome in patients receiving imatinib-based second line.

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