The genus Ptilodontella Kiriakoff, 1967 (the type species Bombyx cucullina Denis & Schiffermüller, 1775) has been separated from the synonymy with the genus Ptilodon Hübner, 1822 (the type species Phalaena camelina Linnaeus, 1758) and reinstated as a distinct genus (stat. rev.) based on differences in male and female genitalia. Additionally, a new species, Ptilodontella albertisp. n., has been described from the Greater and Lesser Caucasus and the Pontic Mountains spanning northern Turkey, with the type locality in the Republic of South Ossetia. This new species differs from its close relatives Ptilodontella cucullina (Denis & Schiffermüller, 1775) comb. rev. and Ptilodontella saerdabensis (Daniel, 1938) comb. n. in the shape of antennal rami and the genitalia of both sexes. Variability in wing patterns among species is demonstrated and is regarded as an unreliable feature for distinguishing the three species. The distribution boundary between the new species and P. cucullina lies between the lowland Pontic steppe and the foothills of the Greater Caucasus, while the boundary between the new species and P. saerdabensis is situated between the Lesser Caucasus and the Alborz Mountains. None of these species are found to fly sympatrically.
BACKGROUND:The standard treatment for older patients (aged ≥70 years) with localised, unresectable head and neck squamous-cell carcinoma is standard fractionated radiotherapy (SF-RT). However, its high toxicity and multiple fractions lead physicians to deliver tailored hypofractionated split-course radiotherapy (HSC-RT). The aim of the study was to compare these two radiotherapy methods in older patients. METHODS:This non-inferiority, multicentre, open-label, randomised controlled trial was done in 30 treating centres (cancer centres, university and general hospitals, and private clinics) across France and Monaco. Patients aged 70 years or older, assessed as frail by geriatric evaluation, with stage II-IV head and neck squamous-cell carcinoma and in curative intent were randomly assigned (1:1) to receive either SF-RT (70 Gy, 35 fractions over 7 weeks) or HSC-RT (55 Gy, 20 fractions, two courses of 2 weeks with 2 weeks stop). Randomisation was done by minimisation, and physicians and patients were not masked to the treatment group. The primary endpoint was the proportion of patients alive with complete locoregional response at 6 months, analysed in all randomly assigned patients (intention-to-treat population). The non-inferiority margin was set at 16%. The study was sponsored by the Groupe d'Oncologie Radiothérapie Tête et Cou (GORTEC) and is registered with ClinicalTrials.gov, NCT01864850. FINDINGS:Between Oct 21, 2013, and Aug 22, 2018, 102 patients were randomly assigned to the HSC-RT group and 100 patients to the SF-RT group. One patient in the HSC-RT group refused treatment and follow-up and so was excluded, resulting in 101 patients in the HSC-RT group. Median age was 82 years (IQR 77-86); 145 (72%) were male and 56 (28%) were female. Median follow-up for overall survival was 56·6 months (IQR 41-69). In the intent-to-treat population, 35 (35%) of 101 patients were alive with complete locoregional response at 6 months in the HSC-RT group versus 33 (33%) of 100 patients in the SF-RT group (difference +2%, 95% CI -11 to 15). In the per-protocol population, 35 (36%) of 97 patients were alive with complete locoregional response at 6 months in the HSC-RT group versus 33 (35%) of 95 patients in the SF-RT group (difference +1%, -12 to 15). Median overall survival was 13·0 months (95% CI 10·3 to 17·0) in the HSC-RT group versus 18·9 months (14·3 to 30·9) in the SF-RT group (hazard ratio 1·32, 95% CI 0·97 to 1·81). Eight patients died between radiotherapy start and 30 days after radiotherapy end (five [5%] in the HSC-RT group and three [3%] in the SF-RT group). One patient in the HSC-RT group had a grade 4 adverse event (kidney failure), as did four in the SF-RT group (two mucositis, one septic shock, and one hemiplegia). Acute adverse events grade 3-5 occurred in 33 (36%) of 91 patients in the HSC-RT group and in 44 (47%) of 93 patients in the SF-RT group (p=0·13; difference -11%, 95% CI -25 to 3). INTERPRETATION:Compared with SF-RT, HSC-RT did not decrease the 6-month complete locoregional response rate and could be an option for frail older patients. However, given the survival results, it should only be offered to patients deemed unsuitable for SF-RT after geriatric assessment. FUNDING:French programme PAIR-VADS 2011 (sponsored by the French National Cancer Institute, Fondation ARC, and Ligue Contre le Cancer), GEMLUC, and GEFLUC.
INTRODUCTION:Trimodal therapy (TMT) is a viable option for muscle-invasive bladder cancer (MIBC), but the optimal chemotherapy regimen remains unclear. This phase II randomized trial (NCT01495676) compared cisplatin (CDDP) with twice-weekly gemcitabine (GEM) and radiation therapy (RT) with CDDP plus RT. METHODS:Patients with pT2-pT3N0M0 MIBC, after macroscopically complete transurethral resection (TURBT), received RT (63 Gy to the bladder, 45 Gy to the pelvis, 1,8 Gy/ fraction) with chemotherapy (CDDP 20 mg/m2/day for 4 days every 21 days alone or plus GEM 25 mg/m2 twice weekly). The primary endpoint was 2-year disease-free survival (DFS); secondary endpoints included overall survival (OS) and toxicities. A 1:2 randomization was planned to include 36 patients in the control arm and 73 patients in the experimental arm. RESULTS:Sixty-nine patients were included: 24 in the RT/CDDP arm and 45 in the RT/CDDP/GEM arm. The median follow-up was 63 months. Two-year DFS was similar between groups (58.3% CI95% [36.6-77.9] vs. 60.0% CI95% [44.3-74.3]), with median DFS of 29.8 (RT/CDDP) vs. 37.4 (RT/CDDP/GEM) months. OS at 24 and 60 months was 91.3% [IC 95% 69.5-97.8] and 66.8% [IC 95% 39.6-83.9] (RT/CDDP) vs. 66.7% % [IC 95% 50.2 - 78.8] and 53.7% [IC 95% 37.2 - 67.6] (RT/CDDP/GEM). Toxicity profiles were comparable except for increased cytopenias in the GEM arm. CONCLUSIONS:Adding GEM to CDDP did not improve 2-year DFS in MIBC patients treated with TMT. Results should be interpreted cautiously due to early study termination and insufficient accrual.
BACKGROUND:Hypofractionated radiotherapy is standard for whole-breast radiotherapy, but 50 Gy in 25 fractions (5-week radiotherapy) is still standard in many countries when nodal radiotherapy is needed for morbidity concerns. The UNICANCER HypoG-01 trial aimed to assess morbidity and efficacy of hypofractionated locoregional radiotherapy delivering 40 Gy in 15 fractions (3-week radiotherapy) versus 5-week radiotherapy. METHODS:This non-inferiority, open-label, multicentre, randomised phase 3 trial, conducted in 29 centres in France, included female patients 18 years and older, with invasive breast carcinoma requiring nodal irradiation after complete microscopic resection of the primary tumour. Patients were randomly allocated in a 1:1 ratio to either 3-week radiotherapy (experimental group) or 5-week radiotherapy (control group) to the regional nodes and thoracic wall or breast. The primary endpoint was ipsilateral arm lymphoedema, defined as a 10% or greater increase in arm circumference at 15 cm proximal, 10 cm distal, or both, to the ipsilateral olecranon relative to baseline and contralateral arm, with a non-inferiority margin on the hazard ratio (HR) of 1·545. This trial was registered at ClinicalTrials.gov (NCT03127995) and is closed to recruitment. FINDINGS:Between Sept 26, 2016, and March 27, 2020, 1265 patients were enrolled, and 1221 were included in per-protocol analysis (median follow-up 4·8 years [IQR 4·01-5·02]), 614 assigned to 3-week radiotherapy and 607 to 5-week radiotherapy. The median age was 58 years (IQR 49-68). Arm lymphoedema occurred in 275 (25%) patients (143 with 3-week radiotherapy and 132 with 5-week radiotherapy). 3-week radiotherapy was non-inferior to 5-week radiotherapy regarding arm lymphoedema risk (HR 1·02 [95% CI 0·79-1·31] pnon-inferiority<0·001), with a 3-year cumulative incidence of 23·4% (95% CI 19·7-27·6) and 22·2% (95% CI 19·5-26·3), respectively. Safety profiles were similar between groups; grade 3 or worse adverse events frequencies were 8% and 13%, respectively. Following French regulation, data on race and ethnicity were not collected. INTERPRETATION:3-week radiotherapy (40 Gy in 15 fractions) was found to be non-inferior to 5-week radiotherapy (50 Gy in 25 fractions) for arm lymphoedema risk and was comparably safe regarding other late normal tissue effects for patients prescribed locoregional radiotherapy for early-breast cancer. FUNDING:French National Cancer Institute.
Poly (ADP-ribose) polymerase inhibitors (PARPi) are approved for the treatment of HER2-negative metastatic breast cancer (MBC) in germline (g)BRCA1/2 pathogenic alteration (m) carriers. Olaparib and talazoparib showed efficacy in MBC patients with somatic (s)BRCA1/2m and/or gPALB2m in phase 2 trials. We aimed to investigate the effectiveness of PARPi in this setting in the real-life ESME cohort. ESME-MBC, a nationwide observational cohort, gathers data on MBC patients treated in 18 French Cancer Centers from 2008 on. We selected all patients treated with PARPi and who had either sBRCA1/2m or gPALB2m MBC. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) from treatment initiation, PFS and OS according to type of mutation, type of PARPi and line of treatment. The Kaplan-Meier method was used to assess survival. Among 35,687 patients included in the ESME database from 2008 to 2022, 57 were eligible for the present analysis (46 with sBRCA1/2m;11 gPALB2m). Median age at treatment was 54 years [31-83]). 39% were triple negative MBC (17 sBRCA1/2m and 5 gPALB2m), 60% HR-positive/HER2-negative (28 sBRCA1/2m and 6 gPALB2m). The median number of treatment lines prior PARPi, including endocrinotherapy, was two [0-9]. PARPi was initiated in first- or second line for 24 patients, representing 64% of triple-negative patients and 42% of HR-positive/HER2-negative patients. 32 patients (56%) received olaparib, 22 talazoparib (39%, all with sBRCA1/2m) and 3 another PARPi. A clinical trial was the context for 36.8% of prescriptions. In the whole population, median PFS and OS were 5.4 [95%CI: 4.3; 8.3] and 13.2 months [11.2; 19.7] respectively. For patients bearing sBRCA1/2m and gPALB2m, median PFS were 4.9 [3.0; 8.2] and 8.3 [3.0; not achieved (NA)] months respectively, and median OS 12.1 [10.4; 19.7] and 17.6 [2.4; NA] months respectively. Median PFS was 4.9 [2.8; 6.7] and 8.2 months [3.9; 13.1] for talazoparib and olaparib respectively; and median OS 12.1 [7.2; 24.3] and 15.0 months [10.1; 26.6]. In this multicenter real-life cohort of MBC patients with a sBRCA1/2 or a gPALB2 mutation, effectiveness of PARPi appeared in line with phase II trials. These data further support the use of olaparib or talazoparib in gPALB2m, and possibly in sBRCA1/2m. P. ROTTIER, L. CHALTIEL, Z. NEVIERE, W. JACOT, A. MAILLIEZ, F. DALENC, T. BACHELOT, E. BRAIN, V. MASSARD, B. SAUTEREY, T. GRINDA, C. BAILLEUX, M. ARDENOS, L. BOSQUET, G. EMILE. Parp inhibitors use in patients in germline palb2 or somatic brca1/2 mutations carriers with metastatic breast cancer: real life data from the esme database [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS2-04-29.
