-
1.
Comparison of 18F-sodium fluoride PET/CT, 18F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France.
Gauthé, M, Zarca, K, Aveline, C, Lecouvet, F, Balogova, S, Cussenot, O, Talbot, JN, Durand-Zaleski, I
BMC medical imaging. 2020;(1):25
Abstract
BACKGROUND The diagnostic performance of 18F-sodium fluoride positron emission tomography/computed tomography (PET/CT) (NaF), 18F-fluorocholine PET/CT (FCH) and diffusion-weighted whole-body magnetic resonance imaging (DW-MRI) in detecting bone metastases in prostate cancer (PCa) patients with first biochemical recurrence (BCR) has already been published, but their cost-effectiveness in this indication have never been compared. METHODS We performed trial-based and model-based economic evaluations. In the trial, PCa patients with first BCR after previous definitive treatment were prospectively included. Imaging readings were performed both on-site by local specialists and centrally by experts. The economic evaluation extrapolated the diagnostic performances of the imaging techniques using a combination of a decision tree and Markov model based on the natural history of PCa. The health states were non-metastatic and metastatic BCR, non-metastatic and metastatic castration-resistant prostate cancer and death. The state-transition probabilities and utilities associated with each health state were derived from the literature. Real costs were extracted from the National Cost Study of hospital costs and the social health insurance cost schedule. RESULTS There was no significant difference in diagnostic performance among the 3 imaging modalities in detecting bone metastases. FCH was the most cost-effective imaging modality above a threshold incremental cost-effectiveness ratio of 3000€/QALY when imaging was interpreted by local specialists and 9000€/QALY when imaging was interpreted by experts. CONCLUSIONS FCH had a better incremental effect on QALY, independent of imaging reading and should be preferred for detecting bone metastases in patients with biochemical recurrence of prostate cancer. TRIAL REGISTRATION NCT01501630. Registered 29 December 2011.
-
2.
Comparison of 5 Different PET Radiopharmaceuticals for the Detection of Recurrent Medullary Thyroid Carcinoma: A Network Meta-analysis.
Lee, SW, Shim, SR, Jeong, SY, Kim, SJ
Clinical nuclear medicine. 2020;(5):341-348
Abstract
PURPOSE The aim of this study is to investigate and compare the performance of different PET radiopharmaceuticals for the detection of recurrent medullary thyroid carcinoma (MTC) by performing a network meta-analysis (NMA) using direct comparison studies with 2 or more PET radiopharmaceuticals. METHODS PubMed and EMBASE were searched for the studies evaluating the performance of PET or PET/CT for the detection of recurrent MTC. The NMA was performed for different PET radiopharmaceuticals in both patient- and lesion-based analyses and with a threshold of serum calcitonin or carcinoembryonic antigen (CEA) levels and calcitonin doubling time. The consistency was evaluated by examining the agreement between direct and indirect treatment effects, and publication bias was assessed by funnel plot asymmetry tests. The surface under the cumulative ranking curve values were obtained to calculate the probability of each PET modality being the most effective diagnostic method. RESULTS A total of 306 patients from 14 direct comparison studies using 5 different PET radiopharmaceuticals (F-FDG, F-DOPA, Ga-somatostatin analogs, 3-O-methyl-6-[F]fluoro-DOPA, and C-methionine) for the detection of recurrent MTC was included. The detection rate of F-DOPA PET was significantly higher than that of FDG PET in both patient- and lesion-based analyses (patient-based analysis: odds ratio, 2.44; 95% confidence interval, 1.4-4.31; lesion-based analysis: odds ratio, 5.74; 95% confidence interval, 1.65-23.4). Among all PET radiopharmaceuticals, F-DOPA showed the highest surface under the cumulative ranking curve value in both patient- and lesion-based analyses regardless of serum calcitonin or CEA levels and calcitonin doubling time. CONCLUSIONS The results from this NMA indicate that F-DOPA PET clearly showed a best performance for the detection of recurrent MTC in both patient- and lesion-based analyses regardless of serum calcitonin or CEA levels and calcitonin doubling time.
-
3.
Diffusion-weighted MRI is not superior to FDG-PET/CT for the detection of neck recurrence in well-differentiated thyroid carcinoma.
Vera, P, Edet-Sanson, A, Quieffin, F, Le Cloirec, J, Bertrand, AS, Cailleaux, M, Menard, JF, Lussey-Lepoutre, C, Callonnec, F
The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of.... 2019;(3):311-320
Abstract
BACKGROUND Management of patients with well-differentiated thyroid carcinoma (WDTC) and positive thyroglobulin (Tg)/negative iodine-131 whole body scintigraphy (WBS) remains challenging. Here, we investigate the specific role of diffusion-weighted magnetic resonance imaging of the neck (DW-MRI) as compared to rhTSH stimulated FDG-PET/CT in such patients. METHODS Patients with WDTC, positive Tg/negative WBS were prospectively enrolled in the study. FDG-PET/CT and neck DW-MRI were performed on the same day after rhTSH stimulation. Neck-US was performed 24 hours after FDG-PET/CT and MRI to guide fine-needle aspiration (FNA). Patients with positive FNA underwent surgery. Patient with negative workup underwent new explorations at 6 and 18 months. RESULTS A total of 86 FDG-PET/CT and 83 DW-MRI tests were performed in 40 patients (23 females; 17 males; 52±16 years). For detection of neck recurrences, sensitivity was equivalent for FDG-PET/CT and to DW-MRI at baseline (46% vs. 43%), at 6 months (30% vs. 20%) and at 18 months (11 vs. 10%). The comparison with a non-weighted Kappa test shows significant concordance between FDG-PET/CT and DW-MRI (K=0.741±0.062; P<0.0001). A relationship was observed between Tg and results of FDG-PET/CT, but not for DW-MRI. FDG-PET/CT permitted to detect iodine-refractory distant metastasis in 4 patients. CONCLUSIONS In Tg-positive/WBS-negative DTC patients, low tumour burden, neck DW-MRI does not provide additional information compared to rhTSH-stimulated FDG-PET/CT. FDG-PET/CT has the best sensitivity, is acceptable for patients, allows whole body exploration and distant metastasis detections, and is correlated with Tg levels.
-
4.
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study.
Cohen, EEW, Soulières, D, Le Tourneau, C, Dinis, J, Licitra, L, Ahn, MJ, Soria, A, Machiels, JP, Mach, N, Mehra, R, et al
Lancet (London, England). 2019;(10167):156-167
Abstract
BACKGROUND There are few effective treatment options for patients with recurrent or metastatic head-and-neck squamous cell carcinoma. Pembrolizumab showed antitumour activity and manageable toxicity in early-phase trials. We aimed to compare the efficacy and safety of pembrolizumab versus standard-of-care therapy for the treatment of head-and-neck squamous cell carcinoma. METHODS We did a randomised, open-label, phase 3 study at 97 medical centres in 20 countries. Patients with head-and-neck squamous cell carcinoma that progressed during or after platinum-containing treatment for recurrent or metastatic disease (or both), or whose disease recurred or progressed within 3-6 months of previous multimodal therapy containing platinum for locally advanced disease, were randomly assigned (1:1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive pembrolizumab 200 mg every 3 weeks intravenously or investigator's choice of standard doses of methotrexate, docetaxel, or cetuximab intravenously (standard-of-care group). The primary endpoint was overall survival in the intention-to-treat population. Safety was analysed in the as-treated population. This trial is registered with ClinicalTrials.gov, number NCT02252042, and is no longer enrolling patients. FINDINGS Between Dec 24, 2014, and May 13, 2016, 247 patients were randomly allocated to pembrolizumab and 248 were randomly allocated to standard of care. As of May 15, 2017, 181 (73%) of 247 patients in the pembrolizumab group and 207 (83%) of 248 patients in the standard-of-care group had died. Median overall survival in the intention-to-treat population was 8·4 months (95% CI 6·4-9·4) with pembrolizumab and 6·9 months (5·9-8·0) with standard of care (hazard ratio 0·80, 0·65-0·98; nominal p=0·0161). Fewer patients treated with pembrolizumab than with standard of care had grade 3 or worse treatment-related adverse events (33 [13%] of 246 vs 85 [36%] of 234). The most common treatment-related adverse event was hypothyroidism with pembrolizumab (in 33 [13%] patients) and fatigue with standard of care (in 43 [18%]). Treatment-related death occurred in four patients treated with pembrolizumab (unspecified cause, large intestine perforation, malignant neoplasm progression, and Stevens-Johnson syndrome) and two patients treated with standard of care (malignant neoplasm progression and pneumonia). INTERPRETATION The clinically meaningful prolongation of overall survival and favourable safety profile of pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma support the further evaluation of pembrolizumab as a monotherapy and as part of combination therapy in earlier stages of disease. FUNDING Merck Sharp & Dohme, a subsidiary of Merck & Co.
-
5.
Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers: The AMATERASU Randomized Clinical Trial.
Urashima, M, Ohdaira, H, Akutsu, T, Okada, S, Yoshida, M, Kitajima, M, Suzuki, Y
JAMA. 2019;(14):1361-1369
-
-
Free full text
-
Abstract
IMPORTANCE Randomized clinical trials of vitamin D supplementation for secondary prevention in patients with cancer are needed, given positive results of observational studies. OBJECTIVE To determine whether postoperative vitamin D3 supplementation can improve survival of patients with digestive tract cancers overall and in subgroups stratified by 25-hydroxyvitamin D (25[OH]D) levels. DESIGN, SETTING, AND PARTICIPANTS The AMATERASU trial, a randomized, double-blind, placebo-controlled trial conducted at a single university hospital in Japan. Enrollment began in January 2010 and follow-up was completed in February 2018. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Of 439 eligible patients, 15 declined and 7 were excluded after operation. INTERVENTIONS Patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/d; n = 251) or placebo (n = 166) from the first postoperative outpatient visit to until the end of the trial. MAIN OUTCOMES AND MEASURES The primary outcome was relapse-free survival time to relapse or death. The secondary outcome was overall survival time to death due to any cause. Subgroups analyzed had baseline serum 25(OH)D levels of 0 to less than 20 ng/mL, 20 to 40 ng/mL, and greater than 40 ng/mL; because of small sample size for the highest-baseline-level group, interactions were tested only between the low- and middle-baseline-level groups. RESULTS All 417 randomized patients (mean age, 66 years; male, 66%; esophageal cancer, 10%; gastric cancer, 42%; colorectal cancer, 48%) were included in the analyses. There was 99.8% follow-up over a median 3.5 (interquartile range, 2.3-5.3) years, with maximal follow-up of 7.6 years. Relapse or death occurred in 50 patients (20%) randomized to vitamin D and 43 patients (26%) randomized to placebo. Death occurred in 37 (15%) in the vitamin D group and 25 (15%) in the placebo group. The 5-year relapse-free survival was 77% with vitamin D vs 69% with placebo (hazard ratio [HR] for relapse or death, 0.76; 95% CI, 0.50-1.14; P = .18). The 5-year overall survival in the vitamin D vs placebo groups was 82% vs 81% (HR for death, 0.95; 95% CI, 0.57-1.57; P = .83). In the subgroup of patients with baseline serum 25(OH)D levels between 20 and 40 ng/mL, the 5-year relapse-free survival was 85% with vitamin D vs 71% with placebo (HR for relapse or death, 0.46; 95% CI, 0.24-0.86; P = .02; P = .04 for interaction). Fractures occurred in 3 patients (1.3%) in the vitamin D group and 5 (3.4%) in the placebo group. Urinary stones occurred in 2 patients (0.9%) in the vitamin D group and 0 in the placebo group. CONCLUSIONS AND RELEVANCE Among patients with digestive tract cancer, vitamin D supplementation, compared with placebo, did not result in significant improvement in relapse-free survival at 5 years. TRIAL REGISTRATION UMIN Identifier: UMIN000001977.
-
6.
A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.
Fujiwara, Y, Mukai, H, Saeki, T, Ro, J, Lin, YC, Nagai, SE, Lee, KS, Watanabe, J, Ohtani, S, Kim, SB, et al
British journal of cancer. 2019;(5):475-480
-
-
Free full text
-
Abstract
BACKGROUND NK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer. METHODS Patients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m2) or PTX (80 mg/m2) on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was progression-free survival (PFS), with a non-inferiority margin of 1.215. RESULTS A total of 436 patients were randomised and 211 patients in each group were included in the efficacy analysis. The median PFS was 8.4 and 8.5 months for NK105 and PTX, respectively (adjusted hazard ratio: 1.255; 95% confidence interval: 0.989-1.592). The median overall survival and overall response rates were 31.2 vs. 36.2 months and 31.6% vs. 39.0%, respectively. The two groups exhibited similar safety profiles. The incidence of peripheral sensory neuropathy (PSN) was 1.4% vs. 7.5% (≥Grade 3) for NK105 and PTX, respectively. The patient-reported outcomes of PSN were significantly favourable for NK105 (P < 0.0001). CONCLUSIONS The primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT01644890.
-
7.
Improved Metastasis- and Disease-Free Survival With Preoperative Sequential Short-Course Radiation Therapy and FOLFOX Chemotherapy for Rectal Cancer Compared With Neoadjuvant Long-Course Chemoradiotherapy: Results of a Matched Pair Analysis.
Markovina, S, Youssef, F, Roy, A, Aggarwal, S, Khwaja, S, DeWees, T, Tan, B, Hunt, S, Myerson, RJ, Chang, DT, et al
International journal of radiation oncology, biology, physics. 2017;(2):417-426
Abstract
PURPOSE To compare treatment and toxicity outcomes between a phase 2 institutional trial of near total neoadjuvant therapy (nTNT) for locally advanced rectal cancer and a similar historical control cohort treated at Washington University in St. Louis with the current US standard of care, defined as neoadjuvant chemoradiotherapy (NCRT), total mesorectal excision (TME), and adjuvant FOLFOX chemotherapy; to expand the comparison to an additional institution, patients treated with similar NCRT at Stanford University were included. METHODS AND MATERIALS Sixty-nine patients with cT3-4N0-2M0 rectal adenocarcinoma enrolled on the Washington University in St. Louis phase 2 study of nTNT were included for analysis. Patients treated at the same institution with conventional NCRT and adjuvant FOLFOX were matched for exact cTNM stage. Forty-one patients treated with NCRT at Stanford University were included in a second analysis. Kaplan-Meier analysis with log-rank test was used to compare local control, distant metastasis-free survival, disease-free survival, and overall survival. RESULTS Median follow-up was 49 and 54 months for nTNT and NCRT, respectively. Pathologic complete response and T-downstaging rates were 28% versus 16% (P=.21) and 75% versus 41% (P<.001) in the nTNT and NCRT cohorts, respectively. Three-year disease-free survival (85% vs 68%, P=.032) was significantly better in the nTNT group. Actuarial 3-year local control (92% vs 96%, P=.36) and overall survival (96% vs 88%, P=.67) were similar. The Stanford cohort had significantly lower clinical stage. After controlling for clinical stage, age, tumor location, institution, and number of chemotherapy cycles, nTNT treatment remained significantly associated with lower risk of recurrence (P=.006). CONCLUSIONS Patients treated with nTNT had higher T-downstaging and superior distant metastasis-free survival and disease-free survival compared with conventional NCRT when matched for tumor location and exact cTNM stage. Near total neoadjuvant therapy remained a significant multivariate predictor for improved outcome when including patients treated with NCRT at another institution.
-
8.
Comparison of quality of life and worry of cancer recurrence between endoscopic and surgical treatment for early gastric cancer.
Choi, JH, Kim, ES, Lee, YJ, Cho, KB, Park, KS, Jang, BK, Chung, WJ, Hwang, JS, Ryu, SW
Gastrointestinal endoscopy. 2015;(2):299-307
Abstract
BACKGROUND The quality of life (QOL) of patients who survive early gastric cancer (EGC) is an area of increasing interest. OBJECTIVE To compare the QOL and degree of worry of cancer recurrence in EGC patients who underwent endoscopic submucosal dissection (ESD) or surgery. DESIGN Cross-sectional study. SETTINGS A tertiary referral center. PATIENTS A total of 565 patients with EGC who received ESD or surgery. INTERVENTION Questionnaires. MAIN OUTCOME MEASUREMENTS QOL was evaluated using the Short-form Health Survey and the European Organization for Research and Treatment of Cancer QOL questionnaires (QLQ-C30 and EORTC-QLQ-STO22). Mood disorders and the worry of cancer recurrence were estimated using the Hospital Anxiety and Depression Scale (HADS) and Worry of Cancer Scale, respectively. RESULTS Questionnaires were completed by 55.7% of the ESD (137/246) and 58.9% of the surgery (188/319) patients. The surgery group had more QOL-related symptomatic and functional problems, including fatigue (P=.044), nausea/vomiting (P=.032), appetite loss (P=.023), diarrhea (P<.001), pain (P=.013), reflux symptoms (P=.005), eating restrictions (P<.001), anxiety (P=.015), taste impairment (P=.011), and poor body image (P<.001). The ESD group had significantly higher worry of cancer recurrence scores after adjusting for covariates, especially when visiting their physicians. The HADS results did not differ between the groups. LIMITATIONS Cross-sectional design. CONCLUSIONS Endoscopic treatment for EGC provides a better QOL, but stomach preservation might provoke cancer recurrence worries. Endoscopists should address this issue for relieving a patient's concern of cancer recurrence during follow-up period after ESD. ( CLINICAL TRIAL REGISTRATION NUMBER WHO ICTRP KCT0000791.).
-
9.
Laparoscopic versus open distal pancreatectomy: a single-institution comparative study.
Zhang, Y, Chen, XM, Sun, DL
World journal of surgical oncology. 2014;:327
Abstract
BACKGROUND This study was designed to compare clinical outcomes for laparoscopic distal pancreatectomy (LDP) and open distal pancreatectomy (ODP) performed at a single institution. METHODS This retrospective study included 43 patients who underwent distal pancreatectomy between 2009 and 2013. The patients were divided into two groups based on the surgical approach: the laparoscopic surgery group (n=20) and the open surgery group (n=23). All clinical data were analyzed retrospectively. RESULTS There were no significant differences in operation time, rate of intraoperative transfusions, complications, or mortality between the two groups. The intraoperative blood loss (210±84.4 mL vs. 420±91.1 mL), first flatus time (1.5±1 d vs. 4±2.5 d), diet start time (2±0.7 d vs. 6±1.8 d), and postoperative hospital stay (8±3.5 d vs. 14±5.5 d) were significantly less in the LDP group than in the ODP group. All patients had negative surgical margins at final pathology. There were no significant differences in the number of lymph nodes harvested (10±2.1 vs. 11±3.2) between the two groups. CONCLUSIONS LDP is a feasible and safe surgical approach as well as ODP, but has the advantages of an earlier return to normal bowel movements, normal diet, and shorter hospital stays than ODP.
-
10.
Diagnostic yield of baseline and follow-up PET/CT studies in ablative therapy for non-small cell lung cancer.
Pou Ucha, JL, Nogueiras Alonso, JM, Alvarez Paez, AM, Suarez Arfenoni, BA, Puig, AS, Lopez Lopez, AM, Barandela Salgado, J, Campos Villarino, LM, Casal Rivas, M, Guitian Iglesias, R
Revista espanola de medicina nuclear e imagen molecular. 2012;(6):301-7
Abstract
Although they have proven effectiveness, radiofrequency and microwave ablation techniques have a high rate of partial responses. Diagnostic studies that anticipate the changes in morphology are essential for earlier detection of residual viable tumor tissue or local recurrences to identify patients who will benefit from a new treatment. Our study has determined the diagnostic yield of PET/CT studies at baseline and follow-up and adequate time between them and the ablation intervention. Seven patients with single tumor lesion with a total of 8 ablations were included. CT and PET/CT studies were performed at baseline and follow-up after ablation. Average times between PET studies at baseline and follow-up and the ablative therapy were 1.8 and 3.4 months, respectively. Mean scores in metabolic activities of the PET at baseline and follow-up were 7.6 and 4.3g/ml of SUVmax, respectively. The Dual Time Point technique helped to identify viable tissue after ablation in 3 cases. Follow-up PET/CT studies have conditioned the various treatment strategies adopted by clinical oncologists. The high yield of the PET/CT study including the Dual Time Point technique may be considered as a study replacement of initial and follow-up Contrast-Enhanced CT before and after treatment with RFA and AMO, this achieving considerable reduction in the exposure to high radiation levels. We propose conducting the first PET/CT follow-up study at 3 months of the RFA and AMO.