Patterns of relapse and treatment outcome after active surveillance or adjuvant carboplatin for stage I seminoma: a retrospective study of the Spanish Germ Cell Cancer Group

Purpose Active surveillance (AS) and adjuvant chemotherapy (AC) with carboplatin are valid alternatives for managing stage I seminoma, and most relapses can be cured with cisplatin-based chemotherapy. However, some reports suggest that AC may modify the classical pattern of recurrences. Methods We analyzed all relapses observed in a series of 879 patients with stage I seminoma included in 4 consecutive studies of the Spanish Germ Cell Cancer Group. After a median follow-up of 67 months, recurrences were detected in 56/467 (12%) low-risk cases on AS and 13/412 (3%) high-risk cases after AC (p < 0.001). The objective was to describe clinical features, treatment and outcome. Univariate comparisons were performed between both groups. Results No significant differences were found between relapses on AS and those after AC in terms of time to relapse (13 vs 17 months), size (26 vs 27 mm), location (retroperitoneum in 88% vs 85%), and method of detection (computed tomography in 77% vs 69%). Treatment consisted of chemotherapy (etoposide + cisplatin ± bleomycin) in 89% and 92%, respectively. Late relapses (after > 3 years) were seen in 11% vs 7.7% (p = NS) and second or successive recurrences in 1.8 vs 23% (p < 0.05). With a median follow-up of 130 moths, two patients died of seminoma-unrelated causes (AS group) and the rest are alive and disease-free. Conclusion In the setting of a risk-adapted treatment of stage I seminoma, the administration of two courses of AC in patients with tumor size > 4 cm and/or rete testis invasion is associated with a higher incidence of second recurrences but does not significantly modify the pattern of relapses or their outcome (AU)

Patterns of relapse and treatment outcome after active surveillance or adjuvant carboplatin for stage I seminoma: a retrospective study of the Spanish Germ Cell Cancer Group.

PURPOSE: Active surveillance (AS) and adjuvant chemotherapy (AC) with carboplatin are valid alternatives for managing stage I seminoma, and most relapses can be cured with cisplatin-based chemotherapy. However, some reports suggest that AC may modify the classical pattern of recurrences. METHODS: We analyzed all relapses observed in a series of 879 patients with stage I seminoma included in 4 consecutive studies of the Spanish Germ Cell Cancer Group. After a median follow-up of 67 months, recurrences were detected in 56/467 (12%) low-risk cases on AS and 13/412 (3%) high-risk cases after AC (p < 0.001). The objective was to describe clinical features, treatment and outcome. Univariate comparisons were performed between both groups. RESULTS: No significant differences were found between relapses on AS and those after AC in terms of time to relapse (13 vs 17 months), size (26 vs 27 mm), location (retroperitoneum in 88% vs 85%), and method of detection (computed tomography in 77% vs 69%). Treatment consisted of chemotherapy (etoposide + cisplatin ± bleomycin) in 89% and 92%, respectively. Late relapses (after > 3 years) were seen in 11% vs 7.7% (p = NS) and second or successive recurrences in 1.8 vs 23% (p < 0.05). With a median follow-up of 130 moths, two patients died of seminoma-unrelated causes (AS group) and the rest are alive and disease-free. CONCLUSION: In the setting of a risk-adapted treatment of stage I seminoma, the administration of two courses of AC in patients with tumor size > 4 cm and/or rete testis invasion is associated with a higher incidence of second recurrences but does not significantly modify the pattern of relapses or their outcome.

Prognostic factors for relapse in stage I seminoma: a new nomogram derived from three consecutive, risk-adapted studies from the Spanish Germ Cell Cancer Group (SGCCG).

BACKGROUND: We aimed to analyze prognostic factors for relapse in stage I seminoma managed by either active surveillance or adjuvant chemotherapy, and to describe the long-term patterns of recurrence in both groups. PATIENTS AND METHODS: From 1994 to 2008, 744 patients were included in three consecutive, prospective risk-adapted studies by the Spanish Germ Cell Cancer Group. Low-risk patients were managed by surveillance and high-risk patients were given two courses of adjuvant carboplatin. Relapses were treated mainly with chemotherapy. Patient age, tumor size, histological variant, pT staging, rete testis invasion, and preoperative serum BHCG levels were assessed for prediction of disease-free survival (DFS). RESULTS: After a median follow-up of 80 months, 63 patients (11.1%) have relapsed: 51/396 (14.8%) on surveillance and 12/348 (3.2%) following adjuvant carboplatin. Actuarial overall 5-year DFS was 92.3% (88.3% for surveillance versus 96.8% for chemotherapy, P = 0.0001). Median time to relapse was 14 months. Most recurrences were located at retroperitoneum (86%), with a median tumor size of 26 mm. All patients were rendered disease-free with chemotherapy (92%), radiotherapy (5%), or surgery followed by chemotherapy (3%). A nomogram was developed from surveillance patients that includes two independent, predictive factors for relapse: rete testis invasion and tumor size (as a continuous variable). CONCLUSION: Long-term follow-up confirms the risk-adapted approach as an effective option for patients with stage I seminoma. The pattern of relapses after adjuvant chemotherapy is similar to that observed following surveillance. A new nomogram for prediction of DFS among patients on surveillance is proposed. Rete testis invasion and tumor size should be taken into account when considering the administration of adjuvant carboplatin. Prospective validation is warranted.

Low-dose beta-lactam plus amikacin in febrile neutropenia: cefepime vs. piperacillin/tazobactam, a randomized trial.

Patients with fever and granulocytopenia are at risk of developing severe infection. We performed a prospective, randomized trial to evaluate the efficacy of low-dose cefepime plus amikacin (C-A) compared to low-dose piperacillin/tazobactam plus amikacin (PT-A). Patients received cefepime (2 g/12 h) plus amikacin (15 mg/kg/day) or piperacillin/tazobactam (4 g/500 mg/8 h) plus amikacin. A total of 317 episodes of febrile granulocytopenia in 190 patients were studied (152 in the C-A group, 165 in the PT-A group). A microbiologically documented infection was present in 53 (35%) episodes in the C-A group and 41 (25%) episodes in the PT-A group (p = ns); a clinically documented infection was observed in 39 (26%) and 47 (28%) episodes, respectively. Toxicity was observed in 6 (4%) episodes in the C-A group and in 5 (3%) episodes in the PT-A group. The antibiotic success rate (no change or addition of antibiotics) was recorded in 89 (59%) and 105 (64%) cases, respectively (p = ns). Mortality related to infection was similar in each arm (3.9% vs. 3.6%). Combination therapy of low-dose beta-lactam with an aminoglycoside achieves very good response rates and low rates of toxicity. It might be an attractive option in an environment of increasing resistance among gram-negative bacteria.

Impacto clínico de la PET con 18FDG en la selección de la terapia de los pacientes oncológicos / Clinical impact of PET-18FDG in selecting the therapy of oncologic patients

Objetivo: Determinar el impacto clínico de la PET en la actitud terapéutica de los pacientes oncológicos.Material y métodos: Hemos incluido en este trabajo los cien primeros estudios oncológicosconsecutivos de PET con 18FDG de cuerpo completo (75 varones/22 mujeres, edad media de 67 años)procedentes de un mismo hospital público de nuestra comunidad. El impacto de la PET se calculó mediantelos resultados de una encuesta enviada a cada uno de los médicos solicitantes de la prueba. Estecuestionario se diseñó fundamentalmente para valorar el tipo de cambio de tratamiento (intramodalidad/intermodalidad) ocasionado tras los hallazgos de la PET.Resultados: Las tres neoplasias estudiadas más frecuentes fueron: carcinoma broncogénico(34%), neoplasia colo-rectal (24%) y nódulo pulmonar solitario (15%). La PET cambió la actitud terapéuticainicialmente prevista en 53 (55%) de los 97 casos evaluados (tipo intramodalidad en 5 e intermodalidaden 48). Diecisiete pacientes (17.5%) candidatos a cirugía curativa fueron finalmente tratadoscon un tratamiento sistémico de quimioterapia con o sin radioterapia. Los médicos encuestadosconsideraron que la PET constituía una herramienta diagnóstica útil en el 69% de los casos y que evitabamaniobras diagnósticas agresivas en 56%.Conclusión: En nuestra serie de pacientes, la PET con FDG ha sido una herramienta diagnósticade gran utilidad. Mejora la estadificación inicial de las neoplasias, en especial del carcinoma broncogénicoy estadifica de forma más precisa la recidiva tumoral de diferentes tipos de tumores, especialmentede la neoplasia colo-rectal. De este modo, la PET ayuda a seleccionar el tratamiento óptimo encada caso, evitando cirugías innecesarias

Purpose: To determine the impact of (F18)2-fluoro-2-deoxy-D-glucose positron emissiontomography (PET-18FDG) in cancer patients.Materials and methods: A standardized questionnaire of one hundred consecutive PET-18FDGoncologic studies (72 men and 22 women, with a median age of 67 years) was sent to all involvedreferring physicians. The questionnaire was designed to determine how the results of the PET-18FDGimaging changed the patients management. The changes were categorized as intramodality andintermodality.Results: The three leading causes of referral were lung cancer (34%), colorectal cancer (24%) andsolitary lung nodules (15%). PET changed patients management in 53 out of 97 evaluated cases (55%)(intramodality management in 5 and intermodality management in 48). Curative surgery was changedto chemotherapy plus radiotherapy in 17 patients (17.5%). PET had some decision-making value in69% patients and avoided unnecessary aggressive diagnostic procedures in 56%.Conclusions: PET has shown to be a useful diagnostic tool in the oncological setting. Itimproves the initial staging of neoplasms, especially of patients with lung cancer, and characterizesthe tumour recurrence, particularly in colorectal neoplasms. PET selects the most appropriatetreatment in each case, avoiding unnecessary surgical interventions

Diabetes mellitus tipo:2 ¿la insulinización en atención primaria mejora el control metabólico? / Type-2 diabetes mellitus: does insulin therapy in primary care improve metabolic control?

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Diabetes mellitus tipo 2: ¿la insulinización en atención primaria mejora el control metabólico? / Type-2 diabetes mellitus: does insulin provision in primary care improve metabolic control?

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[Incidence of urinary bladder cancer in an industrialized area of Spain]. / Incidencia del cáncer de vejiga urinaria en un área industrializada de España.

AIM: To identify all incident cases of bladder cancer in the county of Vallès Occidental (Spain), describe their histopathological characteristics, and make comparisons with other Spanish and European areas. METHOD: The study was carried out from the Corporació Parc Taulí (Sabadell). All new cases of bladder cancer in residents of the county Vallès Occidental, a highly industrialised area of Catalonia (Spain), were included between 1992 and 1994. Incidence rates of bladder cancer were adjusted and were compared with adjusted incidence rates reported by registries in other Spanish and European countries. RESULTS: 485 new cases were identified. Transitional cell carcinomas predominated (95.5%). The majority of tumours were diagnosed in their initial stages, 75.9% being superficial and 62.6% well to moderately differentiated. Bladder cancer was more common in men than in women, but women presented tumours of worse prognosis. The mean age at diagnosis was also higher in women than men (71 vs. 66 years, p = 0.03). The adjusted incidence rate in men (52.2 cases/100,000) was among the highest of the observed areas, whereas for women (5.4 cases/100,000) was relatively low. CONCLUSIONS: The incidence of bladder cancer among men in Vallès Occidental is among the highest in Europe, and intermediate for women. The high male/female ratio seen in all Spanish areas could be attributed to the fact that women in Spain have been less exposed than men to the risk factors, or their exposure occurred more recently.

Phase I-II study of paclitaxel, cisplatin, and gemcitabine in advanced transitional-cell carcinoma of the urothelium. Spanish Oncology Genitourinary Group.

PURPOSE: To determine the maximum-tolerated dose and the antitumor activity of a combination of paclitaxel, cisplatin, and gemcitabine in advanced transitional-cell carcinoma (TCC) of the urothelium. PATIENTS AND METHODS: Patients with measurable, previously untreated, locally advanced or metastatic TCC and with Eastern Cooperative Oncology Group performance status < or = 2 and creatinine clearance > or = 55 mL/min were eligible. Cisplatin was given on day 1 at a fixed dose of 70 mg/m(2). Paclitaxel and gemcitabine were given on days 1 and 8 at increasing dose levels. Cycles were repeated every 21 days to a maximum of six cycles. RESULTS: Sixty-one patients were registered. In phase I, 15 patients were entered at four different dose levels. Dose-limiting toxicity consisted of early onset (after the first cycle) grade 2 asthenia (two of six patients) and grade 3 asthenia (one of six patients) at dose level 4. A paclitaxel dose of 80 mg/m(2) and gemcitabine 1,000 mg/m(2) was recommended for phase II, and 46 additional patients were entered at this level for a total of 49 patients. Main nonhematologic toxicity was grade 2 asthenia in 18 patients, with early onset in five patients, and grade 3 in four patients. Grade 3/4 neutropenia and thrombocytopenia occurred in 27 (55%) and 11 (22%) patients, respectively. Overall, febrile neutropenia was seen in 11 patients, and one toxic death occurred because of neutropenic sepsis. The combination was active at all dose levels. In total, 58 of 61 eligible patients were assessable for response; 16 complete responses (27.6%) and 29 partial responses (50%) were observed for an overall response rate of 77.6% (95% confidence interval, 60% to 98%). The median survival time (MST) available for the phase I part of the study is 24.0 months. MST has not been reached for the whole group with the current follow-up. CONCLUSION: This combination of paclitaxel, cisplatin, and gemcitabine is feasible and highly active in patients with advanced TCC of the urothelium. Further evaluation of this regimen in patients with TCC is warranted.

Bladder cancer in the textile industry.

OBJECTIVES: This study examined the occupations and industries at high risk for bladder cancer in an area where the textile industry is plentiful and the incidence of the disease is very high. METHODS: A case-referent study concerning 218 incident bladder cancer cases diagnosed during 1993-1995 in the county of Vallès Occidental, Barcelona, was carried out. A reference group (N=344) was selected from municipal lists matched to the cases by age, gender, and area of residence. All the subjects were personally interviewed, and a complete occupational history was abstracted together with other sociodemographic and life-style factors. All odds ratios (OR) and 95% confidence intervals (95% CI) were adjusted for age, gender, and smoking. RESULTS: No overall excess risk was found forever having worked in the textile industry (OR 1.13, 95% CI 0.79-1.63) nor for specific sectors of this industry (ie cotton, wool, silk). An excess risk was observed for spinners and winders employed for more than 20 years (OR 3.28, 95% CI 1.08-9.97) and for machine setters employed between 1960 and 1974 (OR 4.26, 95% CI 1.09-16.7). CONCLUSIONS: The results of this study do not support the findings of some earlier studies for an increased bladder cancer risk in the textile industry. However, some elevated risks were observed among the workers with the highest exposures.

Small cell carcinoma of the urinary bladder treated with chemotherapy and radiotherapy: results in five cases.

Small cell carcinoma of the bladder is a rare and highly aggressive tumor. We report our experience with 5 consecutive patients treated with systemic chemotherapy and adjuvant radiotherapy. TNM stages were T2N0M0 (1 patient), T3aN0M0 (3 patients) and T3bN1M0 (1 patient). The chemotherapy protocol was the one used with small cell lung cancer patients at our hospital: six cycles of alternating PE/CAV (PE: cisplatin, etoposide; CAV: cyclophosphamide, doxorubicin, vincristine). Cystoscopy was performed after the third cycle. Four out of 5 patients were free of macroscopic disease. The fifth patient had persistent lesions and was treated by cystectomy. This patient developed a local-regional recurrence 4 months later and died shortly afterwards. Four patients completed the planned six cycles. Cystoscopy with bladder biopsy was then performed on each, and all had complete remission. They were treated with external radiotherapy (45 Gy pelvis, 60 Gy bladder). One patient had invasive bladder recurrence 12 months later and cystectomy was performed. At the last follow-up 42 months later, he was alive and well. The other 3 patients were alive and free of disease 60, 48 and 27 months after diagnosis, respectively. These results are clearly more favorable than previous reports. Cystectomy might, therefore, be unnecessary in some patients.

[Pancoast's syndrome: difficulties in its diagnosis]. / Tumor de Pancoast: dificultades para su diagnóstico.

We present four patients with pancoast tumor diagnosed between 6 to 13 months after the appearance of symptoms. In three of the patients, the presence of old pulmonary apical fibrous lesions complicated diagnosis by simple radiology. Clinical suspicion of the tumor provided the basis for further complementary explorations which confirmed the apical lesion: TC in two patients and RM in the third. Three patients histological diagnosis was obtained by aspirative transthoracic punction. The late diagnosis resulted in the treatment being purely palliative in three cases. It should be stressed that when presented with persistent shoulder pain, clinicoradiological assessment need to be exhaustive in order to make an early diagnosis.

[Extrabronchial small-cell carcinoma: apropos 6 cases]. / Carcinoma de célula pequeña extrabronquial: a propósito de 6 casos.

Extrabronchial small cell carcinoma (ESCC) is an infrequent tumor with controversial histogenesis, clinical evolution and therapeutic strategy. The aim of this study was to know the immunohistochemical features and the clinical evolution of patients diagnosed of ESCC during a 10 year period. All the diagnoses of small cell carcinoma (bronchial and extrabronchial) carried out by the Unit of Pathology between 1980-1989 were reviewed. In all the ESCC an immunohistochemical study was performed with three neuroendocrine markers, chromogranin, neurospecific enolase and synaptophysin. The clinical evolution of the patients is described. The 6 patients with ESCC represented 4.7% of all the small cell carcinomas. The primary localization was: parotid, urinary bladder, the skin, maxillary sinus and esophagus (2 patients). In five cases positivity was observed for one or more of the neuroendocrine markers. In two cases the ESCC was associated with differentiated cell populations (squamous carcinoma). The diagnosis of ESCC logically obliges the bronchial origin and the presence of ectopic hormonal secretion syndromes to be discarded. The administration of chemotherapy regimes used in small cell lung carcinoma is advised.

Anticipatory nausea and vomiting: prevalence and predictors in chemotherapy patients.

One hundred and seventy-five patients selected at random were prospectively studied. All patients were assessed at least after the first cycle of treatment by a self-report questionnaire which covered the occurrence of nausea and vomiting 24 before chemotherapy, as well as information regarding 22 clinical parameters. Forty-six (26%) patients developed anticipatory nausea. 'Intolerable' posttreatment vomiting and age under 45 were statistically significant parameters (p less than 0.05) in the multivariate analysis. Twenty-one (12%) of the 175 patients experienced anticipatory vomiting. Three variables, age under 45, 'intolerable' posttreatment vomiting and more than three cycles of treatment were found to be significant (p less than 0.05). The relative risk of developing anticipatory nausea and vomiting according to combination of significant clinical predictors in the multivariate analysis is proposed. Therefore recognition of these clinical predictors may serve as a marker for patients with high risk of presenting anticipatory nausea and vomiting, who may benefit from prophylactic behavioral approaches.

Long-term survival in small cell carcinoma of the lung.

We analyzed the long-term survivors in a group of 255 patients with newly diagnosed small cell carcinoma of the lung (SCCL) between January 1978 and July 1983. Long-term survivors were defined as those patients free of cancer 2 years after initiation of therapy. Only 6 patients (2.5%) were free of disease at this time. Two patients relapsed at 29 and 40 months from the start of chemotherapy. Both patients were retreated with chemotherapy, and one of them achieved a complete response. Despite the increase in median survival in SCCL with chemotherapy over the past 10 years, long-term prognosis remains very poor employing standard treatments.

Follow-up of breast cancer stages I and II. An analysis of some common methods.

A retrospective analysis of the follow-up methodology was done in 343 cases of breast cancer Stages I and II, in order to ascertain the effectiveness of the explorations performed and the usefulness of the follow-up program. The actuarial probability of relapse at 6 years was 35% for the 237 patients with negative axillary nodes and 46% for the 106 patients with nodal involvement. Fifty-eight per cent of the relapses were detected by the patients themselves, 24% of relapses were found by physical examination and 9% of relapses were discovered in chest radiographs, leading to 91% of relapses diagnosed by combination of these explorations. The authors conclude that follow-up methodology for these patients could be limited to the above-mentioned methods, without significant reduction of curability or survival possibilities after relapse.