News Article | December 15, 2016
LUGANO-SINGAPORE, 16 December, 2016 - Asian head and neck cancer patients live longer with the immunotherapy pembrolizumab than the overall population, according to a sub-analysis of the KEYNOTE-012 trial presented at the ESMO ASIA 2016 Congress in Singapore.1 Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide," said lead author Dr Makoto Tahara, chief, Department of Head and Neck Medical Oncology, National Cancer Centre Hospital East, Chiba, Japan. "The overall incidence of HNSCC in the Asia Pacific region is approximately 300,000 new cases per year, which is more than half of the total cases worldwide." Recurrent/metastatic HNSCC is commonly treated in the first line with cetuximab, platinum, and 5-fluorouracil, known as the EXTREME regimen, which has demonstrated a median overall survival of ten months. Patients who progress on first line therapy or are platinum refractory have a median overall survival of less than six months. Pembrolizumab is a humanised monoclonal immunoglobulin G4 antibody that blocks the interaction between programmed death (PD)-1 and PD-ligand (PD-L)1 and PD-L2. It has shown antitumour activity in several types of cancer. The initial KEYNOTE-012 trial in 60 patients showed the clinical activity of pembrolizumab administered at 10 mg/kg every two weeks.2 A fixed dose of 200 mg every three weeks was then evaluated in 132 patients.3 "A fixed-dose has several advantages including safety, convenience, reduction of waste, and adherence," said Tahara. Today researchers report the results of a sub-analysis of the safety and efficacy of pembrolizumab in the 26 Asia Pacific patients who received the fixed dose for 24 months until disease progression or adverse events. Median overall survival was better in Asians than the overall population (11.5 months versus 8.4 months). Disease control rate was better in Asians (50.5% versus 37.9% overall). The tumour shrank in a smaller proportion of Asians (50%) than the overall group (61%). There was no difference in overall response rate between the two populations (19.2% in Asians versus 18.2% overall). Responses lasted for more than 12 months in 80% of Asian patients, which was similar to the overall population (86%). Median durations of response were not reached in both populations. The safety profile and incidence of treatment related adverse events were generally similar between the two groups. There were no treatment related deaths. Tahara said: "The fixed dose of pembrolizumab was well tolerated in Asia Pacific patients with recurrent/metastatic head and neck cancer. Although the Asian population was small, our findings suggest that they have better median overall survival with pembrolizumab than a mixed population. The clinical benefit of the fixed dose of pembrolizumab in the first and second line treatment of recurrent/metastatic head and neck cancer is being evaluated head-to-head with standard of care chemotherapy in phase 3 trials around the world, including Asia Pacific." Commenting on the results, Dr Gopal Iyer, chief of head and neck surgery, National Cancer Centre Singapore, said: "This trial focused on a difficult group of patients with recurrent and metastatic squamous cell cancer who have a very poor prognosis. There was a decent response rate in the overall group and in the Asian subgroup, which is encouraging. A clinical trial is needed in a purely Asian cohort to confirm the better median overall survival and disease control rate in Asian patients." "On the flip side, the drug is extremely expensive and with no endpoint in terms of when to stop treating," said Iyer. "This will raise a lot of questions about who is going to pay for it and how to decide who deserves the drug." He concluded: "This trial enrolled patients regardless of PD-L1 status and I wonder whether response rate would increase by using that as a biomarker. There's a clear dichotomy with immunotherapy drugs in that patients either respond or they don't. We need to conduct immune profiling of Asians and other populations so that we can find a biomarker that identifies who will respond even before we treat them." 1 Abstract 359O_PR - 'Efficacy and safety of pembrolizumab (MK-3475) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Subset analyses for Asia-pacific patients in KEYNOTE-012 (KN-012) B2 cohort' will be presented by Makoto Tahara during the Proffered Paper and Poster Discussion session 'Head and neck cancer': on Friday, 16 December, 16:30 - 18:00 (SGT). 2 Seiwert TY, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol. 2016; 17:956-965. doi: 10.1016/S1470-2045(16)30066-3. Epub 2016 May 27. 3 Chow LQ, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol. 2016 Sep 19. pii: JCO681478. [Epub ahead of print] Abstract 360O_PR - 'Efficacy and safety of nivolumab for recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in Asia: CheckMate 141 subgroup analysis' will be presented by Y Hasegawa during the Proffered Paper and Poster Discussion session 'Head and neck cancer': on Friday, 16 December, 16:30 - 18:00 (SGT). This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO and ESMO cannot be held responsible for the accuracy of the data. Commentators quoted in the press release have complied with the ESMO Declaration of Interests. About the European Society for Medical Oncology ESMO is the leading professional organisation for medical oncology. Comprising more than 15,000 oncology professionals from over 130 countries, we are the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment. Founded in 1975, ESMO has European roots and a global reach: we welcome oncology professionals from around the world. We are a home for all oncology stakeholders, connecting professionals with diverse expertise and experience. Our educational and information resources support an integrated, multi-professional approach to cancer treatment. We seek to erase boundaries in cancer care as we pursue our mission across oncology, worldwide. http://www. Follow the conference on Twitter by using the hashtag #ESMOAsia16
Makhija C.,University of Nebraska Medical Center |
Su Y.B.,Head and Neck Medical Oncology |
Goldner W.,University of Nebraska Medical Center
Thyroid | Year: 2015
Background: The choroid is a rare site of thyroid cancer metastases, and has been described in patients with evidence of advanced breast, lung, and prostate carcinomas. To the authors' knowledge, only seven reported cases exist with choroidal metastasis secondary to papillary thyroid carcinoma (PTC). This study describes an additional patient with metastatic PTC with simultaneous appearance of choroidal mass and cutaneous deposits while on systemic therapy with a tyrosine kinase inhibitor (TKI). These infrequent sites of metastasis are typically associated with a dismal prognosis following the diagnoses. However, this patient has not shown evidence of choroid or cutaneous recurrence one year following local targeted and systemic therapy. Patient findings: The case is presented of a 70-year-old male with widely metastatic PTC to the lymph nodes, lung, and mediastinum who was found to have choroidal metastasis six years after his initial diagnosis. Summary: The patient was asymptomatic and was found to have an incidental right choroidal mass on routine ophthalmology exam. Magnetic resonance imaging of the orbit revealed an isolated right choroid lesion suspicious for melanoma or metastasis. Concurrent to this discovery, he was noted to have progression of the lung and mediastinal disease along with new dermal lesions on the chest wall suspicious for dermal metastasis. Both the choroid and dermal metastases occurred while being on a TKI. Given his previous history of male breast carcinoma, a biopsy of the choroid was performed, which confirmed PTC. The patient developed endophthalmitis and subsequently underwent enucleation of the right eye. The choroid mass was completely excised, measured 3.5 mm×9.5 mm with negative margins, and histopathology was consistent with metastatic PTC. Pulmonary, mediastinal, and cutaneous lesions regressed after external beam radiation therapy, following which systemic therapy was changed to a different multikinase inhibitor. Conclusion: A rare and unique case is reported of choroidal metastasis from PTC that presented with concurrent new dermal metastasis in addition to lung and mediastinal lymph node progression. Furthermore, the patient developed choroid and dermal lesions while on a TKI and remained stable without recurrence in these regions after switching to an alternate multikinase inhibitor. © 2015, Mary Ann Liebert, Inc.