18F-DCFPyL PET/CT for primary staging in 160 high-risk prostate cancer patients; metastasis detection rate, influence on clinical management and preliminary results of treatment efficacy.

PURPOSE: Prostate-specific membrane antigen (PSMA) PET/CT shows better diagnostic performance for detection of lymph node and bone metastases as compared to conventional imaging. Studies of PSMA PET/CT in primary staging comprise highly selected patient cohorts. This study evaluates 18F-DCFPyL PET/CT as first-line imaging modality for primary staging of high-risk prostate cancer. MATERIAL: From February 2018 until April 2019, all patients with high-risk prostate cancer received 18F-DCFPyL PET/CT for staging of prostate cancer. Baseline characteristics, findings at 18F-DCFPyL PET/CT, number and type of required additional diagnostic procedures, findings at additional diagnostic procedures, and effects of therapy on PSA levels for all patients treated with curative intent were collected and evaluated. RESULTS: One hundred-sixty patients were included in the study of which 90 (56%) had evidence of metastasized disease (N1, M1a, M1b and, M1c in 49%, 28%, 31%, and 3% respectively). Additional diagnostic imaging was needed in 2/160 patients (1%) because of equivocal findings on 18F-DCFPyL PET/CT. Eighty-one patients had evidence of PSMA-positive lymph node metastases, of whom 39 (48%) had no enlarged lymph nodes on CT; 18F-DCFPyL PET detected additional metastatic lymph nodes in 41/42 patients that had evidence of lymph node metastases on CT. 18F-DCFPyL PET altered patients' management in 17% of patients. CONCLUSION: 18F-DCFPyL PET/CT can be used as first-line imaging modality for therapy selection in patients with primary high-risk prostate cancer, without need for further diagnostic imaging procedures in the majority of patients.

Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin.

BACKGROUND: Biliary tract cancer (BTC) is an uncommon cancer with an unfavorable prognosis. Since 2010, the standard of care for patients with unresectable BTC is palliative treatment with gemcitabine plus cisplatin, based on the landmark phase III ABC-02 trial. This current study aims to evaluate the efficacy and safety of gemcitabine and cisplatin in patients with unresectable cholangiocarcinoma and gallbladder cancer in daily practice that meet the criteria for the ABC-02 trial in comparison to patients who did not. METHODS: Patients diagnosed with unresectable BTC between 2010 and 2015 with an indication for gemcitabine and cisplatin were included. We divided these patients into three groups: (I) patients who received chemotherapy and met the criteria of the ABC-02 trial, (II) patients who received chemotherapy and did not meet these criteria and (III) patients who had an indication for chemotherapy, but received best supportive care without chemotherapy. Primary outcome was overall survival (OS) and secondary outcome was progression-free survival (PFS). RESULTS: We collected data of 208 patients, of which 138 (66.3%) patients received first line chemotherapy with gemcitabine and cisplatin. Median OS of 69 patients in group I, 63 patients in group II and 65 patients in group III was 9.6 months (95%CI = 6.7-12.5), 9.5 months (95%CI = 7.7-11.3) and 7.6 months (95%CI = 5.0-10.2), respectively. Median PFS was 6.0 months (95%CI = 4.4-7.6) in group I and 5.1 months (95%CI = 3.7-6.5) in group II. Toxicity and number of dose reductions (p = .974) were comparable between the two chemotherapy groups. CONCLUSION: First-line gemcitabine and cisplatin is an effective and safe treatment for patients with unresectable BTC who do not meet the eligibility criteria for the ABC-02 trial. Median OS, PFS and treatment side effects were comparable between the patients who received chemotherapy (group I vs. group II).

Lipegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in Dutch patients.

BACKGROUND: Chemotherapy (CT)-induced neutropenia and febrile neutropenia (FN) can lead to changes in the treatment plan, potentially worsening the cancer outcome. This study evaluated the effect of the glycopegylated granulocyte-colony stimulating factor lipegfilgrastim, used as primary (PP) or secondary prophylaxis (SP), on treatment modifications in adult patients receiving cytotoxic CT with or without biological/targeted therapy (BT) for solid and haematological tumours. METHODS: This phase 4, prospective, observational study was conducted in eight centres in the Netherlands, in 2015-2017. Other study objectives were to characterise the population of cancer patients receiving lipegfilgrastim, to evaluate the incidence of CT-induced neutropenic events, and to assess safety. RESULTS: Of 142 patients, 73.94% had breast cancer and 55.63% received CT in the adjuvant setting. Most patients received lipegfilgrastim as PP (74.65%) and were at low (34.51%) or high risk (39.44%) of FN. CT dose delays were recorded for 22.64% and 36.11% of patients receiving lipegfilgrastim for PP and SP, respectively. CT dose reductions were recorded for 2.11% of patients; no CT dose omissions and one BT dose omission occurred. FN and grade III/IV neutropenia were reported for 5.63% and 9.86% of patients, respectively; associated hospitalisations were rare. The most frequently lipegfilgrastimrelated adverse events (AE) were myalgia, bone pain, and back pain. Serious AEs (55) were reported for 30 (21.13%) patients. There were two deaths, unrelated to lipegfilgrastim administration. CONCLUSION: Administration of lipegfilgrastim in routine clinical practice in the Netherlands results in limited CT/BT dose modifications and low incidence of neutropenic events, with no new safety concerns.

[Capecitabine-induced ventricular fibrillation]. / Ventrikelfibrilleren door capecitabine.

BACKGROUND: Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of colorectal, gastric and breast carcinoma. Capecitabine has relatively mild side effects. Less known are its potential severe cardiotoxic effects. CASE DESCRIPTION: We report a case of a 61-year-old man recently diagnosed with rectal cancer. Six days after starting with capecitabine, he developed a cardiac arrest due to ventricular fibrillation (VF). Extensive additional diagnostics did not explain the cardiac arrest nor VF. Given the observed time relation between initiation of capecitabine administration and the occurrence of VF, combined with the absence of other causes for VF, we suspect that VF is a likely consequence of capecitabine-induced coronary vasospasm. CONCLUSION: Capecitabine-induced VF is a rare occurrence. With the increasing use of capecitabine for the treatment of various cancers, health professionals should be aware of these potential cardiotoxic side effects.