2017
DOI: 10.1111/bju.14013
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First‐line therapy with dacomitinib, an orally available pan‐HER tyrosine kinase inhibitor, for locally advanced or metastatic penile squamous cell carcinoma: results of an open‐label, single‐arm, single‐centre, phase 2 study

Abstract: Dacomitinib was active and well tolerated in patients with advanced PSCC and may represent an option when combined chemotherapy cannot be administered. Mutations in downstream effectors of EGFR signalling in relation to dacomitinib activity deserve further studies.

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Cited by 79 publications
(43 citation statements)
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References 27 publications
(36 reference statements)
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“…Possible reasons behind those results are the small sample sizes of the recruited cohorts, together with the heterogeneity of inclusion criteria and treatment regimens. Indeed, some of the included patients presented metastatic or bulky nodal disease [13‐14,30], while others had only cN2 localised tumours [11]. To date, no phase 3 study has been conducted on perioperative systemic therapy in pSCC with cN+ disease, but there is one that is currently ongoing.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Possible reasons behind those results are the small sample sizes of the recruited cohorts, together with the heterogeneity of inclusion criteria and treatment regimens. Indeed, some of the included patients presented metastatic or bulky nodal disease [13‐14,30], while others had only cN2 localised tumours [11]. To date, no phase 3 study has been conducted on perioperative systemic therapy in pSCC with cN+ disease, but there is one that is currently ongoing.…”
Section: Discussionmentioning
confidence: 99%
“…Over recent decades, numerous phase 2 trials have investigated the role of systemic neoadjuvant chemotherapy (NAC) in patients with palpable inguinal lymph node disease. Different chemotherapeutic regimens have been tested, including the combination of bleomycin‐vincristine‐methotrexate (BVM) [5,6], bleomycin‐methotrexate‐cisplatin (BMP) [7,8], or 5‐fluorouracil (5‐FU) plus cisplatin (PF) [9,10], as well as more contemporary therapeutic regimens such as paclitaxel‐cisplatin‐ifosfamide (TIP) [11], cisplatin‐5‐FU‐taxane (TPF) [12,13], and the single agent dacomitinib [14]. Nevertheless, none of those regimens clearly demonstrated an OS benefit in patients with pSCC harbouring cN+ disease [15].…”
Section: Introductionmentioning
confidence: 99%
“…It is possible that a potential difference in HPV exposure may play a role in the differences noted for pSCC presentation and outcomes between AAM and CM, and further investigation in this field is needed. Additionally, due to the high likelihood of advanced disease in AAM, we recommend trials with promising, newer, targeted therapies directed towards programmed death‐ligand 1 and epidermal growth factor receptor .…”
Section: Discussionmentioning
confidence: 99%
“…Die Frage nach der unmittelbaren klinischen Bedeutung der Analyse von p16 INK4a ist gegenwärtig nur ungenau zu beantworten. Es liegen erste Überlegungen vor, gezielte und somit personalisierte medikamentöse Therapiestudien für HPV-positive PSCC-Patienten mit metastasierter Erkrankung zu konzipieren [7,12,13,20]. Hierbei könnte dann die immunhistochemische Analyse der p16 INK4a -Expressionsmuster helfen, durch Selektion geeigneter Patienten dann nachfolgend die entsprechenden Targetstrukturen in den weiteren Signalwegen zu analysieren.…”
Section: Diskussionunclassified
“…metastasiertem Peniskarzinom. Die Unterscheidung zwischen HPV-assoziiertem und nicht mit HPV-assoziiertem PSCC ist somit als Upfront-Diagnostik sinnvoll, um dann nachfolgend gezielter die entsprechenden Downstream-Signalwege als individuelle Therapietargets für den Patienten analysieren zu können [12,13].…”
Section: Introductionunclassified