Effectiveness and Safety of Palbociclib plus Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Real-World Results.

BACKGROUND: Real-world data are critical to demonstrate the reproducibility of evidence and the external generalizability of randomized clinical trials. Palbociclib is an oral small-molecule inhibitor of cyclin-dependent kinases 4/6 that has been shown to improve progression-free survival when combined with letrozole or fulvestrant in phase 3 clinical trials. OBJECTIVE: To evaluate real-world outcomes in patients with metastatic breast cancer who received palbociclib in combination with endocrine therapy in routine clinical practice. METHODS: In this retrospective observational multicentre study, data were evaluated for all women with metastatic breast cancer who were treated with palbociclib from April 2017 to September 2019. Treatment response was assessed through progression-free survival according to the Response Evaluation Criteria in Solid Tumors, version 1.1. RESULTS: Fifty-three patients were included in the study, with median age 57 years (range 31-87 years). For all patients treated with palbociclib, median progression-free survival by the end of the study period was 14.4 months (95% confidence interval [CI] 6.2-22.2 months). Twenty-three women who received palbociclib as a first-line treatment did not experience progression-free survival; for these patients, the median treatment duration was 12.1 months (95% CI 1.4-28.0 months). For the 23 patients who received palbociclib as second-line therapy for metastatic breast cancer, median progression-free survival was 13.3 months (95% CI 4.1-22.4 months). Among the 7 women who received palbociclib as third-line therapy, median progression-free survival was 6.0 months (95% CI 0.9-11.1 months). The most common adverse events were hematologic, with grade 3 or 4 neutropenia occurring in 20 (38%) of the 53 patients. CONCLUSIONS: This study provides data from a real-world setting that match the results of previous studies in terms of effectiveness (i.e., progression-free survival) when palbociclib plus endocrine therapy was used as second- or third-line treatment. Palbociclib had appropriate tolerability and a profile of easily manageable adverse effects, with none of the patients suspending their treatment because of toxic effects.

CONTEXTE: Les données du monde réel sont essentielles pour démontrer la reproductibilité des éléments probants et la « généralisabilité ¼ externe des essais cliniques randomisés. Il a été démontré qu'en association avec le létrozole ou le fulvestrant dans les essais cliniques de phase 3, le palbociclib (un inhibiteur oral à petite molécule des kinases dépendantes des cyclines 4/6) améliorait la survie sans progression. OBJECTIF: Évaluer les résultats réels des patientes atteintes d'un cancer du sein métastatique qui ont reçu du palbociclib en association avec un traitement endocrinien dans le cadre d'une pratique clinique de routine. MÉTHODES: Dans cette étude observationnelle rétrospective multicentrique, les données ont été évaluées pour toutes les femmes atteintes d'un cancer du sein métastatique et qui ont été traitées avec du palbociclib d'avril 2017 à septembre 2019. La réponse au traitement a été évaluée par la survie sans progression au moyen des critères RECIST d'évaluation de la réponse des tumeurs solides, version 1.1. RÉSULTATS: Cinquante-trois patientes (âge médian : 57 ans; extrêmes 31­87 ans) ont été incluses dans l'étude. Pour toutes les patientes traitées avec le palbociclib, la survie moyenne sans progression à la fin de la période d'étude était de 14,4 mois (intervalle de confiance à 95 % [IC] 6,2­22,2 mois). Vingt-trois femmes ayant reçu du palbociclib en guise de traitement de première ligne n'ont pas connu de survie sans progression; pour ces patientes, la durée moyenne du traitement était de 12,1 mois (IC à 95 % 1,4­28 mois). Pour les 23 patientes ayant reçu le palbociclib en guise de traitement de deuxième ligne pour le cancer du sein métastatique, la survie moyenne sans progression était de 13,3 mois (IC à 95 % 4,1­22,4 mois). Parmi les 7 femmes ayant reçu le palbociclib en guise de traitement de troisième ligne, la survie moyenne sans progression était de 6,0 mois (IC à 95 % 0,9­11,1 mois). Les effets indésirables les plus fréquents étaient d'ordre hématologique, avec une neutropénie de grade 3 ou 4 survenant chez 20 (38 %) des 53 patientes. CONCLUSIONS: Cette étude fournit des données provenant d'un contexte réel. Elles correspondent aux résultats d'études précédentes en termes d'efficacité (c'est-à-dire « survie sans progression ¼) lorsque le palbociclib, associé à un traitement endocrinien, était utilisé comme traitement de deuxième ou de troisième ligne. Le seuil de tolérance du palbociclib est approprié et son profil d'effets indésirables est facilement gérable : aucune des patientes n'a en effet suspendu son traitement en raison d'effets toxiques.

Cutibacterium Acnes Tetracycline Resistance Profile in Patients with Acne Vulgaris, in a Colombian Dermatologic Center. / Perfil de resistencia a la tetraciclina de Cutibacterium acnes en pacientes con acné vulgar en un centro dermatológico de Colombia.

INTRODUCTION: Acne is a chronic inflammatory disease, in which different events intervene in its pathogenesis, one of which is Cutibacterium acnes (C. acnes). Resistance of this bacteria to different antimicrobials used in treatment has been described in different regions of the world. The purpose of the study is to estimate the resistance of C. acnes to cyclins in patients with moderate and severe acne over 18 years of age. MATERIALS AND METHODS: An analytical cross-sectional study was carried out. Samples were taken from inflammatory lesions with a comedone extractor. The content of the samples was incubated in an anaerobic atmosphere to grow C. acnes. Finally, the susceptibility of C. acnes to tetracycline, minocycline and doxycycline was determined. RESULTS: Samples were taken from 147 patients, of which 129 showed growth of C. acnes, finding that 5.43% of the strains were resistant to tetracycline, 5.43% to doxycycline, 0.78% to minocycline and cross resistance between doxycycline and tetracycline in all the cases. An association was found between resistance and being 25 years of age or older. No association was found with the prior use of antibiotics, a history of misuse of oral or topical antibiotics, and other demographic and clinical characteristics evaluated. CONCLUSIONS: The resistance found of C. acnes to cyclines was lower than that reported in other studies. Although no relationship was found with the previous use of antibiotics, it is a factor described in previous studies, which is why the proper use of antibiotics is imperative to avoid the appearance of resistance.

Prurigo pigmentosa in a fair-skinned European woman: Dramatic improvement with doxycycline.

INTRODUCTION: Prurigo pigmentosa is a rare inflammatory, pruriginous skin disease seen predominantly in young Asian women, with average age of onset in the mid-20s. OBSERVATION: A 25-year-old fair-skinned European woman presented with a two-year history of pruriginous skin lesions recurring fortnightly. The initial lesions were inflammatory papules, which first emerged on the back of the neck before spreading to the shoulders, below the breasts and the back. The papules resolved leaving a reticular hyperpigmented network that gradually worsened after each episode. The clinical presentation and histopathological findings were consistent with a diagnosis of prurigo pigmentosa. Doxycycline 200mg/day was initiated, with rapid resolution, absence of any further flare-ups and gradual regression of the reticular pigmentation. DISCUSSION: Prurigo pigmentosa is a skin disease of stereotypical presentation marked by frequent inflammatory flare-ups involving the trunk that are followed by periods of remission with residual hyperpigmentation. Herein we report a case observed in a fair-skinned French female subject. It is important that dermatologists are able to recognize it and distinguish it from other forms of pruriginous papular dermatosis, owing to the dramatic efficacy of tetracyclines in controlling the inflammatory flares and in reducing the adverse aesthetic impact of hyperpigmentation.

[Pityriasis lichenoides: not always a clear-cut diagnosis!] / Pithyriasis lichénoïde: diagnostic pas toujours aussi facile!

Pityriasis lichenoides is a rare inflammatory dermatosis occurring in young subjects. It evolves into rashes on the trunk and the limbs which regress spontaneously. We here report a particular case of pityriasis lichenoides whose diagnosis was adjusted due to the scar appearance of the lesions. The patient was treated with cyclin and phototherapy, with a favorable outcome.

[Clinical patterns and treatment of pyoderma gangrenosum in a French department]. / Caractéristiques cliniques et traitement du pyoderma gangrenosum dans la Marne.

BACKGROUND: Pyoderma gangrenosum (PG) is a rare inflammatory neutrophilic dermatosis for which accurate epidemiological data are limited and therapy remains a challenge. The primary study aim was to examine all cases of PG observed in our regional department over a 15-year period in order to describe the relevant characteristics and outcome under therapy. PATIENTS AND METHODS: The medical records of all patients with PG from 1997 to 2012 in the Marne department of France were studied retrospectively. Clinical and histological characteristics, comorbidities, therapeutic modalities and outcome were analysed. RESULTS: Forty-two patients were included (30 women, 12 men). A classical, ulcerative form was found in 39 cases and PG was multifocal in 28 cases. The number of lesions did not differ according to age or the presence of comorbidities. The most frequent first-line treatments were doxycycline (23 cases) and oral corticosteroids (15 cases), regardless of age, number of lesions or existence of comorbidities. Complete remission of PG was obtained in 38 cases (median time to remission: 3 months), with relapse occurring in 17 patients (median time to relapse: 12 months after treatment withdrawal). After a median follow-up of 46 months, 8 patients had died (median time to death: 26 months after treatment initiation). CONCLUSION: This is the first large French series of patients presenting PG and enabling determination of the annual incidence within the Marne department at around 4.6 cases/1000,000 inhabitants. Our study illustrates the value of first-line treatment with tetracycline, which merits confirmation by further prospective, controlled studies.