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1.
BMC Cancer ; 21(1): 593, 2021 May 24.
Article in English | MEDLINE | ID: mdl-34030643

ABSTRACT

BACKGROUND: ATLAS evaluated the efficacy and safety of the PARP inhibitor rucaparib in patients with previously treated locally advanced/unresectable or metastatic urothelial carcinoma (UC). METHODS: Patients with UC were enrolled independent of tumor homologous recombination deficiency (HRD) status and received rucaparib 600 mg BID. The primary endpoint was investigator-assessed objective response rate (RECIST v1.1) in the intent-to-treat and HRD-positive (loss of genome-wide heterozygosity ≥10%) populations. Key secondary endpoints were progression-free survival (PFS) and safety. Disease control rate (DCR) was defined post-hoc as the proportion of patients with a confirmed complete or partial response (PR), or stable disease lasting ≥16 weeks. RESULTS: Of 97 enrolled patients, 20 (20.6%) were HRD-positive, 30 (30.9%) HRD-negative, and 47 (48.5%) HRD-indeterminate. Among 95 evaluable patients, there were no confirmed responses. However, reductions in the sum of target lesions were observed, including 6 (6.3%) patients with unconfirmed PR. DCR was 11.6%; median PFS was 1.8 months (95% CI, 1.6-1.9). No relationship was observed between HRD status and efficacy endpoints. Median treatment duration was 1.8 months (range, 0.1-10.1). Most frequent any-grade treatment-emergent adverse events were asthenia/fatigue (57.7%), nausea (42.3%), and anemia (36.1%). Of 64 patients with data from tumor tissue samples, 10 (15.6%) had a deleterious alteration in a DNA damage repair pathway gene, including four with a deleterious BRCA1 or BRCA2 alteration. CONCLUSIONS: Rucaparib did not show significant activity in unselected patients with advanced UC regardless of HRD status. The safety profile was consistent with that observed in patients with ovarian or prostate cancer. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov (NCT03397394). Date of registration: 12 January 2018. This trial was registered in EudraCT (2017-004166-10).


Subject(s)
Carcinoma, Transitional Cell/drug therapy , Indoles/administration & dosage , Poly(ADP-ribose) Polymerase Inhibitors/administration & dosage , Urinary Bladder Neoplasms/drug therapy , Administration, Oral , Aged , BRCA1 Protein/genetics , BRCA2 Protein/genetics , Carcinoma, Transitional Cell/genetics , Carcinoma, Transitional Cell/mortality , Carcinoma, Transitional Cell/secondary , DNA Repair , Female , Follow-Up Studies , Humans , Indoles/adverse effects , Loss of Heterozygosity , Male , Middle Aged , Poly(ADP-ribose) Polymerase Inhibitors/adverse effects , Progression-Free Survival , Response Evaluation Criteria in Solid Tumors , Urinary Bladder/pathology , Urinary Bladder Neoplasms/genetics , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/pathology
2.
Clin. transl. oncol. (Print) ; 23(4): 882-891, abr. 2021. graf
Article in English | IBECS | ID: ibc-220925

ABSTRACT

Background The studies IMvigor 210 cohort 2 and IMvigor211 evaluated the efficacy of atezolizumab in patients with locally advanced or metastatic urothelial cancer (mUC) upon progression to platinum-based chemotherapy worldwide. Yet, the real impact of this drug in specific geographical regions is unknown. Materials and methods We combined individual-level data from the 131 patients recruited in Spain from IMvigor210 cohort 2 and IMvigor211 in a pooled analysis. Efficacy and safety outcomes were assessed in the overall study population and according to PD-L1 expression on tumour-infiltrating immune cells. Results Full data were available for 127 patients; 74 (58%) received atezolizumab and 53 (42%) chemotherapy. Atezolizumab patients had a numerically superior median overall survival although not reaching statistical significance (9.2 months vs 7.7 months). No statistically significant differences between arms were observed in overall response rates (20.3% vs 37.0%) or progression-free survival (2.1 months vs 5.3 months). Nonetheless, median duration of response was superior for the immunotherapy arm (non-reached vs 6.4 months; p = 0.005). Additionally, among the responders, the 12-month survival rates seemed to favour atezolizumab (66.7% vs 19.9%). When efficacy was analyzed based on PD-L1 expression status, no significant differences were found. Treatment-related adverse events of any grade occurred more frequently in the chemotherapy arm [46/57 (81%) vs 44/74 (59%)]. Conclusion Patients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab (AU)


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Carcinoma, Transitional Cell/secondary , Ureteral Neoplasms/drug therapy , Cohort Studies , Disease-Free Survival , Treatment Outcome , Ureteral Neoplasms/pathology , Spain
3.
Clin Transl Oncol ; 23(4): 882-891, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32897497

ABSTRACT

BACKGROUND: The studies IMvigor 210 cohort 2 and IMvigor211 evaluated the efficacy of atezolizumab in patients with locally advanced or metastatic urothelial cancer (mUC) upon progression to platinum-based chemotherapy worldwide. Yet, the real impact of this drug in specific geographical regions is unknown. MATERIALS AND METHODS: We combined individual-level data from the 131 patients recruited in Spain from IMvigor210 cohort 2 and IMvigor211 in a pooled analysis. Efficacy and safety outcomes were assessed in the overall study population and according to PD-L1 expression on tumour-infiltrating immune cells. RESULTS: Full data were available for 127 patients; 74 (58%) received atezolizumab and 53 (42%) chemotherapy. Atezolizumab patients had a numerically superior median overall survival although not reaching statistical significance (9.2 months vs 7.7 months). No statistically significant differences between arms were observed in overall response rates (20.3% vs 37.0%) or progression-free survival (2.1 months vs 5.3 months). Nonetheless, median duration of response was superior for the immunotherapy arm (non-reached vs 6.4 months; p = 0.005). Additionally, among the responders, the 12-month survival rates seemed to favour atezolizumab (66.7% vs 19.9%). When efficacy was analyzed based on PD-L1 expression status, no significant differences were found. Treatment-related adverse events of any grade occurred more frequently in the chemotherapy arm [46/57 (81%) vs 44/74 (59%)]. CONCLUSION: Patients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Ureteral Neoplasms/drug therapy , Urethral Neoplasms/drug therapy , Urinary Bladder Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Agents/adverse effects , B7-H1 Antigen/metabolism , Carcinoma, Transitional Cell/metabolism , Carcinoma, Transitional Cell/mortality , Carcinoma, Transitional Cell/secondary , Cohort Studies , Female , Humans , Lymphocytes, Tumor-Infiltrating/metabolism , Male , Middle Aged , Progression-Free Survival , Spain , Survival Rate , Treatment Outcome , Ureteral Neoplasms/metabolism , Ureteral Neoplasms/mortality , Ureteral Neoplasms/pathology , Urethral Neoplasms/metabolism , Urethral Neoplasms/mortality , Urethral Neoplasms/pathology , Urinary Bladder Neoplasms/metabolism , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/pathology
4.
Clin. transl. oncol. (Print) ; 21(1): 64-74, ene. 2019. tab
Article in English | IBECS | ID: ibc-183345

ABSTRACT

The goal of this article is to provide recommendations about the management of muscle-invasive (MIBC) and metastatic bladder cancer. New molecular subtypes of MIBC are associated with specific clinical-pathological characteristics. Radical cystectomy and lymph node dissection are the gold standard for treatment and neoadjuvant chemotherapy with a cisplatin-based combination should be recommended in fit patients. The role of adjuvant chemotherapy in MIBC remains controversial; its use must be considered in patients with high-risk who are able to tolerate a cisplatin-based regimen, and have not received neoadjuvant chemotherapy. Bladder-preserving approaches are reasonable alternatives to cystectomy in selected patients for whom cystectomy is not contemplated either for clinical or personal reasons. Cisplatin-based combination chemotherapy is the standard first-line protocol for metastatic disease. In the case of unfit patients, carboplatin-gemcitabine should be considered the preferred first-line chemotherapy treatment option, while pembrolizumab and atezolizumab can be contemplated for individuals with high PD-L1 expression. In cases of progression after platinum-based therapy, PD-1/PD-L1 inhibitors are standard alternatives. Vinflunine is another option when anti-PD-1/PD-L1 therapy is not possible. There are no data from randomized clinical trials regarding moving on to immuno-oncology agents


No disponible


Subject(s)
Humans , Carcinoma, Transitional Cell/therapy , Urinary Bladder Neoplasms/therapy , Muscle Neoplasms/therapy , Antineoplastic Agents, Immunological/therapeutic use , Antineoplastic Agents/therapeutic use , Neoplasm Invasiveness/pathology , Muscle Neoplasms/secondary , Cystectomy/methods , Practice Patterns, Physicians'
5.
Clin Transl Oncol ; 21(1): 64-74, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30565086

ABSTRACT

The goal of this article is to provide recommendations about the management of muscle-invasive (MIBC) and metastatic bladder cancer. New molecular subtypes of MIBC are associated with specific clinical-pathological characteristics. Radical cystectomy and lymph node dissection are the gold standard for treatment and neoadjuvant chemotherapy with a cisplatin-based combination should be recommended in fit patients. The role of adjuvant chemotherapy in MIBC remains controversial; its use must be considered in patients with high-risk who are able to tolerate a cisplatin-based regimen, and have not received neoadjuvant chemotherapy. Bladder-preserving approaches are reasonable alternatives to cystectomy in selected patients for whom cystectomy is not contemplated either for clinical or personal reasons. Cisplatin-based combination chemotherapy is the standard first-line protocol for metastatic disease. In the case of unfit patients, carboplatin-gemcitabine should be considered the preferred first-line chemotherapy treatment option, while pembrolizumab and atezolizumab can be contemplated for individuals with high PD-L1 expression. In cases of progression after platinum-based therapy, PD-1/PD-L1 inhibitors are standard alternatives. Vinflunine is another option when anti-PD-1/PD-L1 therapy is not possible. There are no data from randomized clinical trials regarding moving on to immuno-oncology agents.


Subject(s)
Muscle Neoplasms/therapy , Practice Guidelines as Topic/standards , Urinary Bladder Neoplasms/therapy , Clinical Trials as Topic , Combined Modality Therapy , Disease Management , Humans , Muscle Neoplasms/secondary , Neoplasm Invasiveness , Prognosis , Societies, Medical , Urinary Bladder Neoplasms/pathology
6.
Ann Oncol ; 28(7): 1517-1522, 2017 Jul 01.
Article in English | MEDLINE | ID: mdl-28419193

ABSTRACT

BACKGROUND: Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. PATIENTS AND METHODS: This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. RESULTS: Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. CONCLUSION: This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously. TRIAL NUMBER: NCT01830231.


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Taxoids/therapeutic use , Urinary Bladder Neoplasms/drug therapy , Urothelium/drug effects , Vinblastine/analogs & derivatives , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Carcinoma, Transitional Cell/mortality , Carcinoma, Transitional Cell/secondary , Disease Progression , Disease-Free Survival , Europe , Female , Humans , Liver Neoplasms/secondary , Male , Middle Aged , Survival Analysis , Taxoids/adverse effects , Time Factors , Treatment Outcome , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/pathology , Urothelium/pathology , Vinblastine/adverse effects , Vinblastine/therapeutic use
7.
Ann Oncol ; 25(6): 1222-8, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24608201

ABSTRACT

BACKGROUND: Although sarcomas account for only 1% of all solid tumours, patients with sarcomas comprise a larger proportion of patients entering phase I trials, due to the limited number of registered or active drugs for these diseases. To help in patient selection, we evaluated the utility of the predictive Royal Marsden Score which had been derived in carcinoma patients. In addition, we analysed efficacy and toxicity regarding the sarcoma population enrolled in phase I trials. PATIENTS AND METHODS: We used data from a European Database comprising 2182 patients treated in phase I trials in 14 European institutions between 2005 and 2007. RESULTS: One hundred and seventy-eight patients diagnosed with advanced sarcoma or other mesenchymal tumours were identified and accounted for 217 phase I trial participations during the study period. Histological type, class of drug, number of metastatic sites, high serum lactate dehydrogenase activity (LDH), low albumin and high white blood cell count were independent prognostic factors. Poor performance status (PS), liver metastases and high leucocyte count were associated with increased risk of early death. The class of drug used was the strongest predictor of progression-free survival (PFS) duration, inhibitors of angiogenesis and histone deacetylase giving the best results. Poor PS, high serum LDH and low lymphocyte count correlated with shorter PFS. In this heterogeneous population, PFS with investigational agents appeared comparable with that previously published for patients receiving standard treatments beyond first line. CONCLUSION: Prognostic factors in sarcoma patients do not differ from a broader phase I population. Efficacy measures suggest that some patients with sarcoma derive benefit from therapy in this setting which could therefore be considered for patients with no remaining standard therapeutic option.


Subject(s)
Clinical Trials, Phase I as Topic , Sarcoma/drug therapy , Adult , Aged , Antineoplastic Agents/therapeutic use , Databases, Factual , Europe , Female , Humans , Male , Middle Aged , Survival Analysis , Treatment Outcome , Young Adult
8.
Clin. transl. oncol. (Print) ; 16(1): 102-106, ene. 2014. tab, ilus
Article in English | IBECS | ID: ibc-127527

ABSTRACT

PURPOSE: To evaluate the efficacy and toxicity of docetaxel regimen as second-line after failure of a platinum-based chemotherapy. METHODS: Between May 2005 and June 2008, we retrospectively analyzed the data of 22 patients who had evidence of disease progression after one prior platinum-based regimen for metastatic urothelial carcinoma. Patients were treated with two different docetaxel dose schedules: (1) docetaxel 60 mg/m(2) every 21 days for unfit patients or (2) docetaxel 75 mg/m(2) every 21 days for fit patients. RESULTS: Median number of docetaxel cycles was three. Overall disease control rate was 18 %. Of the 22 patients, no patient achieved complete or partial response and four patients had stable disease. Median progression-free survival was 1.67 months and median overall survival was 3.12 months. Neutropenia was the most common adverse event. CONCLUSIONS: This study identifies that docetaxel as second-line chemotherapy has low activity and was associated with significant toxicity (AU)


No disponible


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Taxoids/therapeutic use , Urinary Bladder Neoplasms/drug therapy , Kaplan-Meier Estimate , Carcinoma, Transitional Cell/mortality , Disease-Free Survival , Retrospective Studies , Urinary Bladder Neoplasms/mortality
9.
Clin Transl Oncol ; 16(1): 102-6, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23606355

ABSTRACT

PURPOSE: To evaluate the efficacy and toxicity of docetaxel regimen as second-line after failure of a platinum-based chemotherapy. METHODS: Between May 2005 and June 2008, we retrospectively analyzed the data of 22 patients who had evidence of disease progression after one prior platinum-based regimen for metastatic urothelial carcinoma. Patients were treated with two different docetaxel dose schedules: (1) docetaxel 60 mg/m(2) every 21 days for unfit patients or (2) docetaxel 75 mg/m(2) every 21 days for fit patients. RESULTS: Median number of docetaxel cycles was three. Overall disease control rate was 18 %. Of the 22 patients, no patient achieved complete or partial response and four patients had stable disease. Median progression-free survival was 1.67 months and median overall survival was 3.12 months. Neutropenia was the most common adverse event. CONCLUSIONS: This study identifies that docetaxel as second-line chemotherapy has low activity and was associated with significant toxicity.


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Taxoids/therapeutic use , Urinary Bladder Neoplasms/drug therapy , Aged , Aged, 80 and over , Carcinoma, Transitional Cell/mortality , Disease-Free Survival , Docetaxel , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Retrospective Studies , Salvage Therapy , Urinary Bladder Neoplasms/mortality
10.
Br J Cancer ; 107(7): 1025-30, 2012 Sep 25.
Article in English | MEDLINE | ID: mdl-22910320

ABSTRACT

BACKGROUND: Selecting patients with 'sufficient life expectancy' for Phase I oncology trials remains challenging. The Royal Marsden Hospital Score (RMS) previously identified high-risk patients as those with ≥ 2 of the following: albumin <35 g l(-1); LDH > upper limit of normal; >2 metastatic sites. This study developed an alternative prognostic model, and compared its performance with that of the RMS. METHODS: The primary end point was the 90-day mortality rate. The new model was developed from the same database as RMS, but it used Chi-squared Automatic Interaction Detection (CHAID). The ROC characteristics of both methods were then validated in an independent database of 324 patients enrolled in European Organization on Research and Treatment of Cancer Phase I trials of cytotoxic agents between 2000 and 2009. RESULTS: The CHAID method identified high-risk patients as those with albumin <33 g l(-1) or ≥ 33 g l(-1), but platelet counts ≥ 400.000 mm(-3). In the validation data set, the rates of correctly classified patients were 0.79 vs 0.67 for the CHAID model and RMS, respectively. The negative predictive values (NPV) were similar for the CHAID model and RMS. CONCLUSION: The CHAID model and RMS provided a similarly high level of NPV, but the CHAID model gave a better accuracy in the validation set. Both CHAID model and RMS may improve the screening process in phase I trials.


Subject(s)
Clinical Trials, Phase I as Topic/methods , Models, Statistical , Neoplasms/blood , Neoplasms/drug therapy , Platelet Count/methods , Serum Albumin/metabolism , Algorithms , Decision Trees , Endpoint Determination , Female , Humans , Male , Patient Selection , Predictive Value of Tests , Prognosis , Reproducibility of Results , Survival Rate
11.
Clin Transl Oncol ; 12(4): 299-302, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20462840

ABSTRACT

BACKGROUND: The incidence of testicular germ cell tumours (TGCT) is increasing and the improvement in survival may lead to an increased incidence of bilateral tumours. We examined the incidence, prognosis, clinical and histological characteristics, treatment and outcome of patients with bilateral TGCTs based on 15 years of experience from a single institution. MATERIAL AND METHODS: We reviewed the charts from all patients treated for a testicular tumour germ cell at Hospital Vall d'Hebron in Barcelona, Spain. The information was retrospectively obtained from the patients' hospital. All the patients were evaluated with clinical history, physical exam, serum markers (alphaFP, LDH and betahCG), ultrasonographic evaluation of the testicles, computed tomography (CT) scans of the chest, abdomen and pelvis, surgery, location and histology of first and second tumour, treatment after the surgery and follow-up. RESULTS: Of 151 patients with TGCT, 8 (5.3%) developed bilateral tumours, seven (4.6%) were metachronous and one (0.7%) synchronous tumours. Two patients underwent testis-sparing surgery for the second tumour. All the patients are alive without evidence of disease based on physical exam, tumour markers and CT scan. CONCLUSIONS: Survival in patients with bilateral testicular germ cell tumours (BTGCT) is similar to that of patients with unilateral TGCT. There is no standard therapy to treat BTGCT and each patient requires a tailored therapeutic treatment.


Subject(s)
Neoplasms, Germ Cell and Embryonal/pathology , Testicular Neoplasms/pathology , Adult , Humans , Incidence , Male , Neoplasms, Germ Cell and Embryonal/epidemiology , Neoplasms, Germ Cell and Embryonal/therapy , Neoplasms, Multiple Primary/epidemiology , Neoplasms, Multiple Primary/pathology , Neoplasms, Multiple Primary/therapy , Neoplasms, Second Primary/epidemiology , Neoplasms, Second Primary/pathology , Neoplasms, Second Primary/therapy , Prognosis , Testicular Neoplasms/epidemiology , Testicular Neoplasms/therapy , Young Adult
12.
Clin. transl. oncol. (Print) ; 12(4): 299-302, abr. 2010. tab
Article in English | IBECS | ID: ibc-124073

ABSTRACT

BACKGROUND: The incidence of testicular germ cell tumours (TGCT) is increasing and the improvement in survival may lead to an increased incidence of bilateral tumours. We examined the incidence, prognosis, clinical and histological characteristics, treatment and outcome of patients with bilateral TGCTs based on 15 years of experience from a single institution. MATERIAL AND METHODS: We reviewed the charts from all patients treated for a testicular tumour germ cell at Hospital Vall d'Hebron in Barcelona, Spain. The information was retrospectively obtained from the patients' hospital. All the patients were evaluated with clinical history, physical exam, serum markers (alphaFP, LDH and betahCG), ultrasonographic evaluation of the testicles, computed tomography (CT) scans of the chest, abdomen and pelvis, surgery, location and histology of first and second tumour, treatment after the surgery and follow-up. RESULTS: Of 151 patients with TGCT, 8 (5.3%) developed bilateral tumours, seven (4.6%) were metachronous and one (0.7%) synchronous tumours. Two patients underwent testis-sparing surgery for the second tumour. All the patients are alive without evidence of disease based on physical exam, tumour markers and CT scan. CONCLUSIONS: Survival in patients with bilateral testicular germ cell tumours (BTGCT) is similar to that of patients with unilateral TGCT. There is no standard therapy to treat BTGCT and each patient requires a tailored therapeutic treatment (AU)


No disponible


Subject(s)
Humans , Male , Young Adult , Adult , Neoplasms, Germ Cell and Embryonal/pathology , Testicular Neoplasms/pathology , Neoplasms, Germ Cell and Embryonal/epidemiology , Neoplasms, Germ Cell and Embryonal/therapy , Neoplasms, Multiple Primary/epidemiology , Neoplasms, Multiple Primary/pathology , Neoplasms, Multiple Primary/therapy , Neoplasms, Second Primary/epidemiology , Neoplasms, Second Primary/pathology , Neoplasms, Second Primary/therapy , Testicular Neoplasms/epidemiology
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