Karcinom vaječníku/vejcovodu je chronické recidivující onemocnění s nepříznivou prognózou. Novou možností zlepšení prognózy pacientek jsou inhibitory poly(adenosindifosfát-ribóza) polymerázy (PARP), které se používají jako udržovací léčba po primární léčbě nebo po léčbě platina senzitivní recidivy onemocnění. Niraparib je v těchto indikacích určen pro všechny pacientky nezávisle na mutačním statusu. V primární léčbě významně prodlužuje interval bez progrese onemocnění, data vzhledem k celkovému přežití nejsou zatím zralá.
Ovarian/fallopian tube cancer is a chronic recurrent disease with an unfavorable prognosis. A new option to improve the prognosis of patients are poly(adenosinediphosphate-ribose) polymerase (PARP) inhibitors, which are used as maintenance therapy after primary treatment or after treatment of platinum-sensitive recurrence. Niraparib is indicated for all patients in these indications regardless of mutational status. In primary treatment, it significantly prolongs the progression free interval, data with respect to overall survival are not yet mature.
Cílená léčba inhibitory poly(adenosindifosfát-ribóza) polymerázy (PARP) je novou možností léčby pacientek s nově diagnostikovaným karcinomem ovaria, ale i s platina senzitivní recidivou tohoto onemocnění. Účinnost inhibitorů PARP v léčbě platina rezistentního/refrakterního onemocnění nebyla prokázána. Toho času jsou v České republice k dispozici tři inhibitory PARP Jejich indikace v léčbě karcinomu ovaria se mírně liší.
Targeted treatment with poly(ADP-ribose) polymerase (PARP) inhibitors is a new treatment option for patients with newly diagnosed ovarian cancer as well as for patients with platinum-sensitive recurrence of the disease. The efficacy of PARP inhibitors in the treatment of platinum-resistant/refractory disease has not been established. Three PARP inhibitors are available in the Czech Republic. Their indications for use in the treatment of ovarian cancer vary slightly.
- Klíčová slova
- Olaparib, niraparib, rucaparib,
- MeSH
- doba přežití bez progrese choroby MeSH
- klinická studie jako téma MeSH
- lidé MeSH
- nádory vaječníků epidemiologie etiologie farmakoterapie MeSH
- PARP inhibitory aplikace a dávkování ekonomika škodlivé účinky terapeutické užití MeSH
- recidiva MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- přehledy MeSH
BACKGROUND: Models predicting recurrence risk (RR) of cervical cancer are used to tailor adjuvant treatment after radical surgery. The goal of our study was to compare available prognostic factors and to develop a prognostic model that would be easy to standardise and use in routine clinical practice. METHODS: All consecutive patients with early-stage cervical cancer treated by primary surgery in a single referral centre (01/2007-12/2016) were eligible if assessed by standardised protocols for pre-operative imaging and pathology. Fifteen prognostic markers were evaluated in 379 patients, out of which 320 lymph node (LN)-negative. RESULTS: The best predictive model for the whole cohort entailed a combination of tumour-free distance (TFD) ≤ 3.5 mm and LN positivity, which separated two subgroups with a substantially distinct RR 36% and 6.5%, respectively. In LN-negative patients, a combination of TFD ≤ 3.5 mm and adenosquamous tumour type separated a group of nine patients with RR 33% from the rest of the group with 6% RR. CONCLUSIONS: A newly identified prognostic marker, TFD, surpassed all traditional tumour-related markers in the RR assessment. Predictive models combining TFD, which can be easily accessed on pre-operative imaging, with LN status or tumour type can be used in daily practice and can help to identify patients with the highest RR.
- MeSH
- adenokarcinom patologie chirurgie MeSH
- dospělí MeSH
- hysterektomie MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru patologie chirurgie MeSH
- lymfatické uzliny patologie chirurgie MeSH
- míra přežití MeSH
- nádory děložního čípku patologie chirurgie MeSH
- následné studie MeSH
- prognóza MeSH
- retrospektivní studie MeSH
- senioři MeSH
- spinocelulární karcinom patologie chirurgie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
OBJECTIVE: Voiding dysfunctions represent a leading morbidity after radical hysterectomy performed in patients with early-stage cervical cancer. The aim of this study was to perform ad hoc analysis of factors influencing voiding recovery in SENTIX (SENTinel lymph node biopsy in cervIX cancer) trial. METHODS: The SENTIX trial (47 sites, 18 countries) is a prospective study on sentinel lymph node biopsy without pelvic lymphadenectomy in patients with early-stage cervical cancer. Overall, the data of 300 patients were analysed. Voiding recovery was defined as the number of days from surgery to bladder catheter/epicystostomy removal or to post-voiding urine residuum ≤50 mL. RESULTS: The median voiding recovery time was three days (5th-95th percentile: 0-21): 235 (78.3%) patients recovered in <7 days and 293 (97.7%) in <30 days. Only seven (2.3%) patients recovered after >30 days. In the multivariate analysis, only previous pregnancy (p = 0.033) and type of parametrectomy (p < 0.001) significantly influenced voiding recovery >7 days post-surgery. Type-B parametrectomy was associated with a higher risk of delayed voiding recovery than type-C1 (OR = 4.69; p = 0.023 vs. OR = 3.62; p = 0.052, respectively), followed by type-C2 (OR = 5.84; p = 0.011). Both previous pregnancy and type C2 parametrectomy independently prolonged time to voiding recovery by two days. CONCLUSIONS: Time to voiding recovery is significantly related to previous pregnancy and type of parametrectomy but it is not influenced by surgical approach (open vs minimally invasive), age, or BMI. Type B parametrectomy, without direct visualisation of nerves, was associated with longer recovery than nerve-sparing type C1. Importantly, voiding dysfunctions after radical surgery are temporary, and the majority of the patients recover in less than 30 days, including patients after C2 parametrectomy.
- MeSH
- dospělí MeSH
- hysterektomie škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory děložního čípku chirurgie MeSH
- prospektivní studie MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- MeSH
- adjuvantní radioterapie klasifikace MeSH
- antitumorózní látky aplikace a dávkování MeSH
- biologická terapie metody MeSH
- hormonální substituční terapie MeSH
- hormony aplikace a dávkování MeSH
- kombinovaná farmakoterapie metody MeSH
- krevní obraz MeSH
- lidé MeSH
- nádory endometria farmakoterapie radioterapie MeSH
- radioterapie klasifikace MeSH
- recidiva MeSH
- riziko MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- přehledy MeSH
The data on the prognostic significance of low volume metastases in lymph nodes (LN) are inconsistent. The aim of this study was to retrospectively analyze the outcome of a large group of patients treated with sentinel lymph node (SLN) biopsy at a single referral center. Patients with cervical cancer, stage T1a-T2b, common tumor types, negative LN on preoperative staging, treated by primary surgery between 01/2007 and 12/2016, with at least unilateral SLN detection were included. Patients with abandoned radical surgery due to intraoperative SLN positivity detected by frozen section were excluded. All SLNs were postoperatively processed by an intensive protocol for pathological ultrastaging. Altogether, 226 patients were analyzed. Positive LN were detected in 38 (17%) cases; macrometastases (MAC), micrometastases (MIC), isolated tumor cells (ITC) in 14, 16, and 8 patients. With the median follow-up of 65 months, 22 recurrences occurred. Disease-free survival (DFS) reached 90% in the whole group, 93% in LN-negative cases, 89% in cases with MAC, 69% with MIC, and 87% with ITC. The presence of MIC in SLN was associated with significantly decreased DFS and OS. Patients with MIC and MAC should be managed similarly, and SLN ultrastaging should become an integral part of the management of patients with early-stage cervical cancer.
- Publikační typ
- časopisecké články MeSH
The quality of pathological assessment is crucial for the safety of patients with cervical cancer if pelvic lymph node dissection is to be replaced by sentinel lymph node (SLN) biopsy. Central pathology review of SLN pathological ultrastaging was conducted in the prospective SENTIX/European Network of Gynaecological Oncological Trial (ENGOT)-CX2 study. All specimens from at least two patients per site were submitted for the central review. For cases with major or critical deviations, the sites were requested to submit all samples from all additional patients for second-round assessment. From the group of 300 patients, samples from 83 cases from 37 sites were reviewed in the first round. Minor, major, critical, and no deviations were identified in 28%, 19%, 14%, and 39% of cases, respectively. Samples from 26 patients were submitted for the second-round review, with only two major deviations found. In conclusion, a high rate of major or critical deviations was identified in the first round of the central pathology review (28% of samples). This reflects a substantial heterogeneity in current practice, despite trial protocol requirements. The importance of the central review conducted prospectively at the early phase of the trial is demonstrated by a substantial improvement of SLN ultrastaging quality in the second-round review.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The need for radical surgery followed by adjuvant chemoradiation may be reduced by abandoning radical surgery in patients in whom lymph node involvement is detected intra-operatively. OBJECTIVES: To analyze, in a retrospective cohort study, the efficacy of the algorithm using intra-operative pathological assessment of sentinel lymph nodes. METHODS: A retrospective single-institution study was carried out, which analyzed data from all consecutive patients with cervical cancer who were referred for primary surgical treatment between May 2005 and December 2015. Inclusion criteria were as follows: (1) TNM stage T1a1 with lymphovascular space invasion, T1a2, T1b, T2a, and selected T2b with incipient parametrial invasion; (2) adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma; (3) no evidence of enlarged suspicious nodes or distant metastases on pre-operative imaging; (4) primary surgery with curative intent; (5) successful detection of sentinel lymph node, at least, unilaterally. All patients had at least one sentinel lymph node detected and submitted for frozen section evaluation. When sentinel lymph node involvement was detected intra-operatively, the cervical procedure was abandoned and the patient was referred for definitive chemoradiation. Radical surgery was completed in patients with intra-operative negative sentinel lymph nodes. The reliability of intra-operative sentinel lymph node assessment was evaluated by calculating the sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. RESULTS: The study included a total of 309 patients. Sentinel lymph nodes were detected bilaterally in 86% of the patients. Lymph node positivity was detected intra-operatively in 18 (6%) patients in whom the cervical procedure was abandoned. Adjuvant radiotherapy after completed radical surgery was given to 29 (9%) patients, including 20 patients with macrometastases (8) or micrometastases (12) reported from the final histology, eight patients with positive parametria (all ≤3 mm), and one patient with a positive vaginal resection margin. The sensitivity, specificity, positive predictive value, and negative predictive value for the intra-operative detection of lymph node positivity (macrometastases or micrometastases) was 47% (95% CI 31% to 64%), 100%, 100%, and 93% (95% CI 90% to 96%), respectively. A total of 18 (6%) patients were spared combined treatment owing to the intra-operative sentinel lymph node triage; 29 patients (9%) received combined treatment with both radical surgery and adjuvant radiotherapy CONCLUSIONS: Of 47 patients with high-risk prognostic risk factors (lymph node, parametria, or surgical margin involvement), combined treatment was successfully avoided in 18 (38%). Despite an effort to triage the patients intra-operatively, 9% received a combination of cervical procedure and adjuvant chemoradiation, mostly owing to the low sensitivity of the frozen section in the detection of micrometastases and macrometastases.
- MeSH
- algoritmy MeSH
- dodržování směrnic statistika a číselné údaje MeSH
- dospělí MeSH
- karcinom patologie terapie MeSH
- kombinovaná terapie statistika a číselné údaje MeSH
- lidé středního věku MeSH
- lidé MeSH
- lymfatické metastázy MeSH
- nádory děložního čípku patologie terapie MeSH
- peroperační péče MeSH
- retrospektivní studie MeSH
- sentinelová uzlina patologie chirurgie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- bevacizumab terapeutické užití MeSH
- cisplatina terapeutické užití MeSH
- humanizované monoklonální protilátky terapeutické užití MeSH
- kombinovaná farmakoterapie MeSH
- metastázy nádorů farmakoterapie MeSH
- nádory děložního čípku terapie MeSH
- paclitaxel terapeutické užití MeSH
- recidiva MeSH
- Publikační typ
- přehledy MeSH
