INTRODUCTION: Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce. METHODS: In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m2 in cycle 1, increasing to 80 mg/m2 if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more). RESULTS: One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events. CONCLUSIONS: In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule. CLINICAL TRIAL REGISTRATION NUMBER: EudraCT 2014-003860-19.
- Klíčová slova
- Administration, Chemotherapy, Disease control rate, HR+/HER2-advanced breast cancer, Metronomic, Oral, Vinorelbine, Weekly administration,
- MeSH
- doba přežití bez progrese choroby MeSH
- lidé MeSH
- metronomické podávání léků MeSH
- nádory prsu * MeSH
- protokoly antitumorózní kombinované chemoterapie MeSH
- prsy metabolismus MeSH
- receptor erbB-2 metabolismus MeSH
- vinblastin MeSH
- vinorelbin MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- receptor erbB-2 MeSH
- vinblastin MeSH
- vinorelbin MeSH
BACKGROUND: For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with maintenance chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma. METHODS: RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine 25 mg/m2 on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m2, on days 1-28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov, number NCT00339118, and follow-up is ongoing. FINDINGS: Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive maintenance chemotherapy. Median follow-up was 60·3 months (IQR 32·4-89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6-83·2) with maintenance chemotherapy versus 69·8% (62·2-76·2) without maintenance chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45-1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2-90·9) with maintenance chemotherapy versus 73·7% (65·8-80·1) without (HR 0·52 [95% CI 0·32-0·86]; p=0·0097). Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved. INTERPRETATION: Adding maintenance chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials. FUNDING: Fondazione Città della Speranza, Association Léon Berard Enfant Cancéreux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.
- MeSH
- alveolární rhabdomyosarkom farmakoterapie mortalita patologie MeSH
- časové faktory MeSH
- cyklofosfamid aplikace a dávkování škodlivé účinky MeSH
- dítě MeSH
- embryonální rhabdomyosarkom farmakoterapie mortalita patologie MeSH
- hodnocení rizik MeSH
- indukce remise MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- přežití po terapii bez příznaků nemoci MeSH
- progrese nemoci MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- udržovací chemoterapie * škodlivé účinky mortalita MeSH
- vinorelbin aplikace a dávkování škodlivé účinky MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Argentina MeSH
- Brazílie MeSH
- Evropa MeSH
- Izrael MeSH
- Názvy látek
- cyklofosfamid MeSH
- vinorelbin MeSH
OBJECTIVES: Adjuvant chemotherapy (AC) in non-small cell lung cancer (NSCLC) has become a standard of care in patients with stages IIA, IIB, and IIIA after complete tumor resection. Utilization and outcome of AC in routine practice is described in a few studies, with non-conclusive results. MATERIALS AND METHODS: This retrospective study included consecutive patients with NSCLC who underwent curative-intent surgery. Data of AC uptake in stages IB (tumor of ≥4 cm in diameter), II, and IIIA, and reasons of AC omission were evaluated according to medical records. Mortality risk among patients treated with surgery (only) and different types of AC in routine practice was compared. RESULTS: AC was applied to 79% of patients with stages IB (tumor of ≥4 cm in diameter), II, and IIIA, and was associated with an improved median of overall survival (HR = 0.69; 95% CI = 0.44-1.06). Significantly longer survival was achieved in the sub-group treated with platinum and oral vinorelbine (HR = 0.575, 95% CI = 0.339-0.974), and the longest survival was among patients treated with oral vinorelbine and cisplatin (HR = 0.371, 95% CI = 0.168-0.820). CONCLUSIONS: AC utilization should be based on co-operation between surgeons, pneumo-oncologists, and patients. Rational use of AC offers better survival in routine practice.
- Klíčová slova
- Non-small cell lung cancer, adjuvant chemotherapy uptake, real-world study, survival,
- MeSH
- adjuvantní chemoterapie * metody statistika a číselné údaje MeSH
- analýza přežití MeSH
- antitumorózní látky terapeutické užití MeSH
- cisplatina terapeutické užití MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mezioborová komunikace MeSH
- nádory plic * farmakoterapie mortalita patologie terapie MeSH
- nemalobuněčný karcinom plic * farmakoterapie mortalita patologie chirurgie MeSH
- pneumektomie * metody statistika a číselné údaje MeSH
- retrospektivní studie MeSH
- senioři MeSH
- spotřeba léčiv statistika a číselné údaje MeSH
- staging nádorů MeSH
- vinorelbin terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Názvy látek
- antitumorózní látky MeSH
- cisplatina MeSH
- vinorelbin MeSH
OBJECTIVES: Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with Stage IIA, IIB or IIIA non-small cell lung cancer (NSCLC) after complete resection. Results obtained for Stage IB were not conclusive. While vinorelbine plus cisplatin is the preferred choice after resection, combining vinorelbine with carboplatin promises improved compliance and delivery of drugs due to lower toxicity. We evaluated the impact of this option on treatment compliance and survival under real-world conditions. MATERIAL AND METHODS: A prospective, single-arm, multicenter, non-interventional study evaluated the tolerability, dose intensity and survival resulting from adjuvant use of intravenous carboplatin (AUC 5 on day 1) with vinorelbine administered both intravenously (25 mg/m2 on day 1) and orally (60 mg/m2 on day 8) within four cycles of 21 days each. A total of 74 patients with a median age of 64 years were observed. RESULTS: The mean number of accomplished cycles was 3.78, and 62 patients (83.7%) completed all four planned cycles. Relative dose intensity for carboplatin was 88.9%, for intravenous vinorelbine 93.1%, and for oral vinorelbine 83.2%. Median follow-up was 4.73 years. Median disease-specific survival (DSS) was 7.63 years, median overall survival (OS) was 5.90 years, median disease-free survival (DFS0) was 4.43 years, and five-year survival was 56.2%. TNM stage of disease significantly affected DSS and OS. Favorable survival was observed in females, nonsmokers, patients aged over 65 years, patient with prior lobectomy, patients with tumor of squamous histology, and those who finished the planned therapy, but the differences were non-significant. CONCLUSION: Adjuvant carboplatin with vinorelbine switched from intravenous to oral administration was shown to be a favorable regimen with regard to tolerability and safety. Compliance to therapy was high, and survival parameters were promising, showing that applied regimen can be another potential option for adjuvant chemotherapy in patients with NSCLC.
- MeSH
- adjuvantní chemoterapie metody MeSH
- aplikace orální MeSH
- intravenózní podání metody MeSH
- karboplatina aplikace a dávkování MeSH
- lidé MeSH
- nádory plic farmakoterapie mortalita MeSH
- nemalobuněčný karcinom plic farmakoterapie mortalita MeSH
- přežití po terapii bez příznaků nemoci MeSH
- prospektivní studie MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování MeSH
- senioři MeSH
- vinblastin aplikace a dávkování analogy a deriváty MeSH
- vinorelbin MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Názvy látek
- karboplatina MeSH
- vinblastin MeSH
- vinorelbin MeSH
AIM: To assess the burden of disease associated with advanced breast cancer (ABC) treated with oral (VinO) or intravenous vinorelbine (VinIV) from the perspective of patients and caregivers in five European countries. METHODS: This was an observational, prospective, international, multicenter study. Patients were included in the study at the beginning of their second cycle of chemotherapy with vinorelbine and categorized into two groups depending on whether they received VinO or VinIV. At baseline (V0) and at the end of the second cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12 and burden of disease. RESULTS: At baseline, the two groups were well balanced in demographic and clinical characteristics. However, while HER2+ (human epidermal growth factor receptor 2) disease was significantly more frequent in patients receiving VinIV, patients receiving VinO were predominantly treated with single-agent therapy and were older than those treated with VinIV (67.1 years versus 57.7 years [p = 0.05]). As measured with SF-12, patients with VinO had, at end of cycle 1 and end of cycle 2, significantly more favorable outcomes in physical summary score, role physical, role emotional and mental health (all p < 0.05) than those treated with VinIV. Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p < 0.10). From a patient perspective, no major difference was reported on the burden of disease between the two groups, however, a trend for a better" overall impact on daily life" was observed in VinO patients. Major significant differences, showing a lower burden of disease with VinO, were also reported from caregivers. In addition, in patients treated with VinO, mental score was almost similar to the one of the general population. CONCLUSION: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative.
- Klíčová slova
- Advanced breast cancer, Burden of disease, Caregiver, Oral chemotherapy, Oral vinorelbine, Quality of life,
- MeSH
- aplikace orální MeSH
- intravenózní infuze MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu farmakoterapie psychologie MeSH
- osobní újma zaviněná nemocí MeSH
- osoby pečující o pacienty * MeSH
- prospektivní studie MeSH
- senioři MeSH
- vinblastin aplikace a dávkování analogy a deriváty MeSH
- vinorelbin MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
- Názvy látek
- vinblastin MeSH
- vinorelbin MeSH
OBJECTIVE: A combination of vinorelbine and cisplatin is a standard treatment in non-small-cell lung cancer; oral vinorelbine is registered in 45 countries. Pemetrexed and cisplatin are recommended in front-line chemotherapy of non-squamous non-small-cell lung cancer (NS-NSCLC). The objective of this study was to conduct a cost minimization analysis from the perspective of the national health service (NHS) in each of 12 European countries, based on a randomized phase II study in NS-NSCLC (NAVoTRIAL01), with 100 oral vinorelbine plus cisplatin patients (arm A) and 51 pemetrexed plus cisplatin patients (arm B). RESEARCH DESIGN AND METHODS: Country-specific costs and DRG codes considered included those relating to anticancer drugs, administration settings (out-patient/in-patient/at home), serious adverse events (defined as involving hospitalization and considered due to anticancer drugs) and concomitant medications. Relevant costs were calculated based on country-specific reimbursement procedures and official tariffs. MAIN OUTCOME MEASURES: Cost and savings per patient. RESULTS: Using the NHS perspective, savings per patient treated with oral vinorelbine ranged from €1317 (Denmark) to €35,001 (Germany). Expressed as percentages, savings per patient treated with oral vinorelbine compared with pemetrexed ranged between 5% (France) and 83% (Czech Republic). Pooled average costs for each treatment arm across the 12 countries resulted in cost savings for payers of €12,871, favoring oral vinorelbine plus cisplatin. CONCLUSIONS: Given the reported efficacy with both regimens, this pan-European economic analysis provides compelling evidence supporting oral vinorelbine use over pemetrexed for the treatment of NS-NSCLC. Oral vinorelbine provides similar efficacy and an easily manageable safety profile at lower overall cost per patient treated, combined with an easier/more convenient mode of administration. Sensitivity analysis across varied scenarios demonstrated the robustness of the results. The principle weakness of our study was its reliance upon a single small scale study to provide efficacy data, since this is the only study conducted in this specific population of patients. Further large scale trials are needed to confirm these results.
- Klíčová slova
- Cost minimization, Europe, NSCLC, Pemetrexed, Vinorelbine,
- MeSH
- antitumorózní látky * škodlivé účinky ekonomika terapeutické užití MeSH
- cisplatina * škodlivé účinky ekonomika terapeutické užití MeSH
- lidé MeSH
- nádory plic * farmakoterapie epidemiologie MeSH
- náklady a analýza nákladů MeSH
- nemalobuněčný karcinom plic * farmakoterapie epidemiologie MeSH
- vinblastin škodlivé účinky analogy a deriváty ekonomika terapeutické užití MeSH
- vinorelbin MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
- Názvy látek
- antitumorózní látky * MeSH
- cisplatina * MeSH
- vinblastin MeSH
- vinorelbin MeSH
BACKGROUND: Vinorelbine constitutes effective chemotherapy for metastatic breast cancer (MBC) and acts synergistically with trastuzumab in HER-2/neu positive disease. The present study was set out to evaluate the efficacy and safety of vinorelbine when combined with lapatinib, an anti-HER2 tyrosine-kinase inhibitor, as late-line regimen administered beyond previous disease progression on prior lapatinib in patients with HER-2/neu- positive MBC. METHODS: The CECOG LaVie study was designed as open-labeled, single-arm, multicenter phase II trial. Patients had to be pretreated with lapatinib plus chemotherapy, and received lapatinib at a daily dose of 1250 mg in combination with vinorelbine 20 mg/m(2) i.v. on days 1 and 8 of a three-week cycle until disease progression, intolerable toxicity or withdrawal of consent. Progression-free survival (PFS) was defined as primary study endpoint; secondary endpoints included overall survival (OS), response rate according to RECIST 1.1, and safety. The study was terminated early due to poor accrual. RESULTS: A total number of nine patients were included; lapatinib administered beyond disease progression combined with vinorelbine resulted in a median PFS of 7.7 months (95% CI 0.56-14.91) and a median OS of 23.4 months (95% CI 16.61-30.13), respectively. Partial remission was seen in one of nine patients, three patients had stable disease of > six months, whereas the remaining five patients had primary disease progression. In two patients, modification of vinorelbine dose due to toxicity became necessary; no dose modification was needed for lapatinib. The majority of reported adverse events (AE) were grade 1 and 2 in severity with diarrhea being the most commonly observed AE CONCLUSION: In this heavily pretreated patient population, combination of vinorelbine plus lapatinib showed encouraging activity and was characterized by an acceptable safety profile. Despite the low patient number, lapatinib plus vinorelbine may constitute a potential treatment option in heavily pretreated patients with HER-2/neu-positive MBC previously exposed to lapatinib. TRIAL REGISTRATION: EudraCT number 2009-016826-15, (15. 10.2009).
- MeSH
- antitumorózní látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- chinazoliny aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- dospělí MeSH
- kombinovaná farmakoterapie MeSH
- lapatinib MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu farmakoterapie MeSH
- receptor erbB-2 MeSH
- senioři MeSH
- vinblastin aplikace a dávkování škodlivé účinky analogy a deriváty terapeutické užití MeSH
- vinorelbin MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- antitumorózní látky MeSH
- chinazoliny MeSH
- lapatinib MeSH
- receptor erbB-2 MeSH
- vinblastin MeSH
- vinorelbin MeSH
BACKGROUND: The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. PATIENTS AND METHODS: Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 (arm A) or oral vinorelbine 80 mg/m(2) on days 1 and 8 (first cycle 60 mg/m(2)) and cisplatin 80 mg/m(2) on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. RESULTS: Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. CONCLUSION: Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.
- Klíčová slova
- Advanced non–small-cell lung cancer, Chemotherapy, Nonsquamous histologic subtype, Pemetrexed, Vinorelbine,
- MeSH
- analýza přežití MeSH
- aplikace orální MeSH
- cisplatina aplikace a dávkování škodlivé účinky MeSH
- glutamáty aplikace a dávkování škodlivé účinky MeSH
- guanin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- lidé středního věku MeSH
- lidé MeSH
- mezinárodní spolupráce MeSH
- nádory plic farmakoterapie mortalita MeSH
- nemalobuněčný karcinom plic farmakoterapie mortalita MeSH
- neutropenie etiologie MeSH
- pemetrexed MeSH
- progrese nemoci MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- senioři MeSH
- staging nádorů MeSH
- vinblastin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- vinorelbin MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- cisplatina MeSH
- glutamáty MeSH
- guanin MeSH
- pemetrexed MeSH
- vinblastin MeSH
- vinorelbin MeSH
BACKGROUND: Adjuvant chemotherapy became a standard of treatment in completely resected non-small cell lung cancer (NSCLC) based on results of big trials meta-analyses, which proved its influence on the decrease of relative mortality risk and absolute improvement of survival. Adjuvant chemotherapy is routinely used according to tumor stage evaluation, performance status (PS) and age of the patients. It is indicated in stage II and IIIA of NSCLC- in frame of clinical studies also in stage IB, in PS 0-1 and in patients under 75 years. Therapy with cisplatin and vinorelbine is a preferred regimen, as well as other drugs, such as paclitaxel, docetaxel, gemcitabine and pemetrexed. The problem is a relatively small dose intensity applied, due to toxic side effects. AIM: The present work is evaluating contemporary trends of adjuvant therapy in NSCLC according to latest clinical studies, which are finished or running. Efforts are directed to the improvement of treatment effectiveness, decrease of side effects and refinement of patients selection. Potential treatment benefit of better tolerable carboplatin is verified and results of trials with biologically targeted therapy are expected. Large clinical studies are evaluating the effect of tyrosine kinase inhibitors and angiogenesis inhibitors used either in various combinations with chemotherapy or as monotherapy. Application of vaccines is tested. CONCLUSION: Contemporary trend of adjuvant therapy is leading to the appropriate patient selection with regard to analysis of several prognostic and predictive biomarkers; it is proposed that future adjuvant therapy will be more and more personalized.
- MeSH
- adjuvantní chemoterapie MeSH
- cisplatina aplikace a dávkování škodlivé účinky MeSH
- deoxycytidin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- docetaxel MeSH
- gemcitabin MeSH
- karboplatina aplikace a dávkování škodlivé účinky MeSH
- lidé MeSH
- medicína založená na důkazech MeSH
- nádory plic farmakoterapie chirurgie MeSH
- nemalobuněčný karcinom plic farmakoterapie chirurgie MeSH
- paclitaxel aplikace a dávkování škodlivé účinky MeSH
- prognóza MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- staging nádorů MeSH
- taxoidy aplikace a dávkování škodlivé účinky MeSH
- věkové faktory MeSH
- vinblastin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- vinorelbin MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- Názvy látek
- cisplatina MeSH
- deoxycytidin MeSH
- docetaxel MeSH
- gemcitabin MeSH
- karboplatina MeSH
- paclitaxel MeSH
- taxoidy MeSH
- vinblastin MeSH
- vinorelbin MeSH
Nodular sclerosis classical Hodgkin lymphoma, clinical stage IIB with cervical and axillar lymph node involvement was histologically proven in a 47-year-old male patient with a long-lasting history of ichthyosis. Skin histology revealed only nonspecific lichenoid inflammatory changes. Patient was treated with six cycles of combined chemotherapy: doxorubicin, bleomycin, vinblastine and dacarbazine. 15 months after initial treatment the first relapse of Hodgkin lymphoma was histologically confirmed and involvement of lymph nodes was identical with initial staging. Patient was successfully treated with six cycles of chemotherapy: ifosfamide, carboplatinum and etoposide followed by radiotherapy. The above mentioned chemotherapies did not cause serious cutaneous toxicity. 4 years after previous therapy the second relapse of Hodgkin lymphoma occurred with axillar and inguinal lymph node involvement. Skin histology confirmed nonspecific lichenoid inflammatory changes. Patient was treated with three cycles of combined chemotherapy: ifosfamide, gemcitabine, vinorelbine and prednisone. This chemotherapy caused neutropenia WHO grade 4 after each cycle and a serious diffuse toxoallergic cutaneous reaction with bullous erythema developed. Several skin lesions fulfilled criteria for cutaneous WHO grade 3 and 4 toxicity. We assumed that combined toxic effect of gemcitabine and vinorelbine resulted in serious cutaneous toxicity under pre-existing condition of diffuse ichthyosis. The cutaneous toxicity subsequently resolved and residual lymph nodes were irradiated.
- MeSH
- deoxycytidin škodlivé účinky analogy a deriváty terapeutické užití MeSH
- gemcitabin MeSH
- Hodgkinova nemoc komplikace farmakoterapie MeSH
- ichtyóza komplikace MeSH
- ifosfamid škodlivé účinky terapeutické užití MeSH
- léková dermatitida etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- recidiva MeSH
- vinblastin škodlivé účinky analogy a deriváty terapeutické užití MeSH
- vinorelbin MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
- Názvy látek
- deoxycytidin MeSH
- gemcitabin MeSH
- ifosfamid MeSH
- vinblastin MeSH
- vinorelbin MeSH