High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study.

BACKGROUND: In the late 1990s, the use of high-dose chemotherapy (HDCT) and stem-cell rescue held promise for patients with advanced and poor prognosis germ-cell tumors (GCT). We started a randomized phase II trial to assess the efficacy of sequential HDCT compared with cisplatin, etoposide, and bleomycin (PEB). PATIENTS AND METHODS: Patients were randomly assigned to receive four cycles of PEB every 3 weeks or two cycles of PEB followed by a high-dose sequence (HDS) comprising HD-cyclophosphamide (7.0 g/m(2)), 2 courses of cisplatin and HD-etoposide (2.4 g/m(2)) with stem-cell support, and a single course of HD-carboplatin [area under the curve (AUC) 27 mg/ml × min] with autologous stem-cell transplant. Postchemotherapy surgery was planned on responding residual disease in both arms. The primary end point was progression-free survival (PFS). The study was designed to detect a 30% improvement of 5-year PFS (from 40% to 70%), with 80% power and two-sided α at 5%. RESULTS: From December 1996 to March 2007, 85 patients were randomized: 43 in PEB and 42 in HDS arm. Median follow-up was 114.2 months [interquartile range (IQR): 87.7-165.8]. Complete or partial response with normal markers (PRm-) were obtained in 28 (65.1%) and 29 (69.1%) patients, respectively. Five-year PFS was 55.8% [95% confidence interval (CI) 42.8-72.8] and 54.8% (95% CI 41.6%-72.1%) in PEB and HDS arm, respectively (log-rank test P = 0.726). Five-year overall survival was 62.8% (95% CI 49.9-79.0) and 59.3% (95% CI 46.1-76.3). One toxic death (PEB arm) was recorded. CONCLUSIONS: The study failed to meet the primary end point. Furthermore, survival estimates of conventional-dose chemotherapy higher than expected should be accounted for and will likely limit further improvements in the first-line setting. CLINICALTRIALS.GOV: NCT02161692.

Radiotherapy or chemotherapy for clinical stage IIA and IIB seminoma: a systematic review and meta-analysis of patient outcomes.

BACKGROUND: Outcomes of radiotherapy (RT) compared with chemotherapy (CT) remain poorly defined for clinical stage (CS) IIA and IIB seminoma. We aimed to evaluate the current role of the two treatment modalities in this setting of testicular seminoma. PATIENTS AND METHODS: A systematic review and meta-analysis (MA) was carried out to identify all evaluable studies. Search was limited to studies published after 1990 and included the Medline, Embase databases, and abstracts from ASCO (GU), ESMO, AUA, and ASTRO meetings up to April 2014. Sensitivity analyses were applied including the following: CSIIA and CSIIB, paraortic + iliac RT only in both stages, RT dose (≥30 versus <30 Gy), and PEB/EP regimens only. RESULTS: Thirteen studies have been selected for MA on relapse outcome. No randomized trials compared RT and CT. There were 4 prospective and 9 retrospective studies, with a total of 607 patients receiving RT and 283 patients CT. The pooled relapse rate (RR) was similar between the RT [0.11, 95% confidence interval (CI) 0.08-0.14, P for heterogeneity = 0.096, I(2) = 38%] and CT groups (0.08, 95% CI 0.01-0.15, P for heterogeneity <0.001, I(2) = 82.5%). However, in the sensitivity analysis, the pooled RR for RT in CSIIB was 0.12 (95% CI 0.06-0.17) while it was 0.05 (95% CI 0-0.11) for CT. Long-term side-effects and incidence of second cancers were more frequently reported following RT. The overall incidence of nontesticular second malignancies was 0.04 (95% CI 0.01-0.02) in the RT group and 0.02 (95% CI 0.003-0.04) in the CT group. CONCLUSIONS: Although RT and CT appeared to be equal options in CSIIA and IIB seminoma, a trend in favor of CT for a lower incidence of side-effects and RR in CSIIB was found. This evidence is limited by the retrospective quality of studies and their small sample size.

Modified cisplatin, etoposide, and ifosfamide (PEI) salvage therapy for male germ cell tumors: long-term efficacy and safety outcomes.

BACKGROUND: Since 1985, we introduced a modified combination of etoposide, ifosfamide, and cisplatin (PEI) as second-line therapy of adult male germ cell tumors with the aim to reduce toxic effect while maintaining efficacy over the original regimen. PATIENTS AND METHODS: Patients received four cycles of ifosfamide at 2.5 g/m(2) on days 1-2, etoposide, and cisplatin at 100 and 33 mg/m(2), respectively, on days 3-5 every 21 days, followed by surgery. Results were stratified according to the International Germ Cell Consensus Classification Group-2 (IGCCCG-2). RESULTS: From February 1985 to January 2012, 189 patients were treated. 72.6% were IGCCCG-2 intermediate-to-very high risk. Thirty-five patients (18.5%) had a complete response, 67 (35.4%) a marker normalization (PRm-). Median follow-up was 122.1 months (inter-quartile range [IQR]: 71.4-232.0). Two-year progression-free and 5-year overall survival were 34.3% [95% confidence interval (CI) 28.1% to 41.9%] and 42.1% (95% CI 35.3% to 50.2%), respectively. Survival estimates compared favorably with those obtained by conventional dose chemotherapy (CDCT) regimens in each prognostic category. 70.4% of grade 3-4 neutropenia (25.5% febrile neutropenia), 48.1% thrombocytopenia, 21.2% anemia, 3.2% neurotoxic effect, and no severe renal toxic effect were recorded. CONCLUSION: Dose-modified Italian PEI should be considered as an appropriate benchmark for CDCT in the first salvage setting.

CT-guided percutaneous cryoablation of renal masses in selected patients.

PURPOSE: We analysed our experience with computed tomography (CT)-guided percutaneous cryoablation (PCA) in patients who were not surgical candidates or refused surgery for small to medium-sized renal masses. MATERIALS AND METHODS: Two freezing cycles were applied and separated by a passive warming cycle using 1.7- and 2.4-mm cryoprobes under either general anaesthesia or sedation based on patient positioning and respiratory status. Postoperative monitoring included haematological and biochemistry evaluation and CT scan 24 h after PCA. Follow-up consisted of a multislice CT scan at 1 month and every 3 months in the first year then every 6 months thereafter. RESULTS: Thirty-seven patients (38 lesions) underwent 40 PCA procedures; 5/37 (13.5%) had a solitary kidney. Median mass size was 35 (range 12-70) mm. No complications occurred during the procedure. Clavien grade ≥2 anaemia occurred in two patients (5.4 %): one patient required 1 U of packed red blood cells; the other required an arterial embolisation. Serum creatinine did not increase in any case. Two patients showed persisting or recurrent disease at 1 and 9 months, respectively, and both could be re-treated with PCA. All other patients showed a hypodense mass 3 months after PCA, with no contrast enhancement. Subsequent examinations showed that lesion sizes decreased and CT densitometry remained stable or increased minimally, also with no contrast enhancement. CONCLUSIONS: PCA proved relatively easy and safe and could be considered an effective alternative for patients who are not surgical candidates or refuse surgery, as well as in patients with medium-sized lesions.

Characteristics of the case mix, organisation and delivery in cancer palliative care: a challenge for good-quality research.

OBJECTIVES: Palliative care (PC) services and patients differ across countries. Data on PC delivery paired with medical and self-reported data are seldom reported. Aims were to describe (1) PC organisation and services in participating centres and (2) characteristics of patients in PC programmes. METHODS: This was an international prospective multicentre study with a single web-based survey on PC organisation, services and academics and patients' self-reported symptoms collected at baseline and monthly thereafter, with concurrent registrations of medical data by healthcare providers. Participants were patients ≥18 enrolled in a PC programme. RESULTS: 30 centres in 12 countries participated; 24 hospitals, 4 hospices, 1 nursing home, 1 home-care service. 22 centres (73%) had PC in-house teams and inpatient and outpatient services. 20 centres (67%) had integral chemotherapy/radiotherapy services, and most (28/30) had access to general medical or oncology inpatient units. Physicians or nurses were present 24 hours/7 days in 50% and 60% of centres, respectively. 50 centres (50%) had professorships, and 12 centres (40%) had full-time/part-time research staff. Data were available on 1698 patients: 50% females; median age 66 (range 21-97); median Karnofsky score 70 (10-100); 1409 patients (83%) had metastatic/disseminated disease; tiredness and pain in the past 24 hours were most prominent. During follow-up, 1060 patients (62%) died; 450 (44%) <3 months from inclusion and 701 (68%) within 6 months. ANOVA and χ2 tests showed that hospice/nursing home patients were significantly older, had poorer performance status and had shorter survival compared with hospital-patients (p<.0.001). CONCLUSIONS: There is a wide variation in PC services and patients across Europe. Detailed characterisation is the first step in improving PC services and research. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01362816.

Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study.

PURPOSE: Because interferon gave promising results in the management of metastatic renal cell carcinoma in the 1980s, a multicentric randomized controlled trial was planned to compare adjuvant recombinant interferon alfa-2b (rIFNalpha2b) with observation after radical nephrectomy in patients with Robson stages II and III renal cell carcinoma. Overall and event-free survival were to be evaluated together with prognostic factors. PATIENTS AND METHODS: Overall and event-free survival curves for 247 patients (124 controls and 123 treated) were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox's multiple regression models were adopted to perform a joint analysis of treatment and prognostic factors. RESULTS: The 5-year overall and event-free survival probabilities were 0.665 and 0.671, respectively, for controls and 0.660 and 0.567, respectively, for the treated group; the differences were not statistically significant (2P = .861 for overall and 2P = .107 for event-free survival with the log-rank test). Regarding prognostic factors, only grade, pT, and pN demonstrated a significant prognostic role. First-order interactions of treatment with pT and pN category were investigated; a significant interaction was found between pN and treatment. A harmful effect of rIFNalpha2b in the 97 treated pN0 patients and a protective effect in the 13 treated pN2/pN3 patients were statistically significant. CONCLUSION: Adjuvant rIFNalpha2b is not indicated after radical nephrectomy for renal cell carcinoma. The protective effect in the small group of pN2/pN3 patients requires further investigation.

Orchiectomy alone in clinical stage I nonseminomatous testis cancer: a critical appraisal.

Sixty-two consecutive patients with clinical stage I nonseminomatous testicular cancer were entered into a prospective study to receive no treatment after orchiectomy until clinical evidence of recurrent disease. Of 59 evaluable cases, 41 (69.5%) remained continuously disease free for a median duration of 30 months (range, 18 to 46 months), and evidence of metastatic disease developed in 18 patients (30.5%) from 2 to 36 months after orchiectomy. The median disease-free interval for relapsing patients was 6 months. Retroperitoneal metastases developed in ten patients; seven patients had pulmonary metastases, and one patient had progressive elevation of the serum alpha-fetoprotein level. Relapses were significantly more frequent in patients with either embryonal carcinoma, infiltrating testicular cancer (pT greater than 1), peritumoral vascular invasion, or in those who underwent transscrotal biopsy. One patient with relapse refused salvage therapy and died. The remaining 17 patients have been rendered disease free with cisplatin combination chemotherapy and/or surgery. However, two patients showed further recurrence, with one in the lung and the other one also in the retroperitoneal nodes. In our opinion, surveillance following orchiectomy will provide useful information in clinical stage I nonseminomatous testicular cancer, but it is a difficult study. For the time being, it should be restricted to specialized centers only. In the meanwhile, retroperitoneal lymphadenectomy remains the standard treatment.

Paratesticular rhabdomyosarcoma: report from the Italian and German Cooperative Group.

PURPOSE: We report the experience of the German-Italian Cooperative Group with 216 pediatric patients with paratesticular rhabdomyosarcoma treated over 20 years. PATIENTS AND METHODS: At diagnosis, 198 patients had localized disease and 18 had distant metastases. Among the nonmetastatic patients, complete tumor resection was performed in 83% of cases. Evaluation of the retroperitoneal lymph nodes changed over the years from routine surgical staging to radiologic assessment. All patients received chemotherapy, which was reduced in intensity and duration for patients with low-risk features in subsequent protocols. Radiotherapy was administered to 10% of patients. RESULTS: Among 72 patients with a negative retroperitoneal computed tomography (CT) scan, surgical assessment detected nodal involvement in only one case. Among 23 patients with enlarged nodes on CT scans, surgery confirmed nodal spread in 65% of patients. No differences in the rate of nodal involvement were observed over the years. With a median follow-up of 110 months, 5-year survival was 85.5% for the series as a whole, 94.6% for patients with localized disease, and 22.2% for metastatic cases. Retroperitoneal nodal recurrence was the major cause of treatment failure. Univariate analysis revealed the prognostic value of tumor invasiveness, size, and resectability, as well as of nodal involvement and age, in patients with localized tumor. CONCLUSION: The outcome for patients with localized paratesticular rhabdomyosarcoma is excellent, despite the reduction in chemotherapy over the years: an alkylating agent-free and anthracycline-free regimen is adequate treatment for low-risk patients. Surgical assessment of the retroperitoneum must be reserved for patients with enlarged nodes on CT scans. Children over 10 years old carry a higher risk of nodal involvement and relapse.

Critical evaluation of the use of thermography in the investigation of scintigraphically cold thyroid nodules.

One hundred and fifty-five cases of scintigraphically "cold" thyroid nodules were examined telethermographically to determine their thermal gradient. All nodules hyperthermic greater than or equal to 1.5 degrees C were successively removed, as were those (regardless of the thermal gradient) present in men, those in women younger than 21 years and older than 45 years of age, and those clinically suspect, the latter regardless of age or sex of the patient. Of 95 operated cases, 79 proved to be benign or nontumoral nodules, and 16 were carcinomas at histology. Hyperthermia greater than or equal to 1.5 degrees C had been present in 43% of the benign cases and in only 25% of the carcinomas. Out of ten cases were hyperthermia greater than or equal to 2 degrees C, none was a carcinoma. A malignancy was found in 26% of 23 normothermic cases, 17.6% of 34 slightly hyperthermic cases, and only 10.5% of 38 markedly hyperthermic (greater than or equal to 1.5 degrees C) cases. There was no evident correlation between the thermal gradient and the clinical diameter of the thyroid nodule. Our study affirms that thermography is not reliable when used to select cold thyroid nodules for surgical removal.

Empyema following lung cancer resection: risk factors and prognostic value on survival.

A retrospective evaluation of 199 consecutive patients undergoing resection for lung cancer revealed a significantly shorter long-term survival for those in whom empyema developed postoperatively. The overall five-year survival for the empyema group was 24% compared with 35% in the control group (patients without empyema), and the median survival was 15 months for the control group. These differences in survival were not found among patients with Stage I lung cancer. Pneumonectomy proved to be the main risk factor for the occurrence of empyema after operation, but a minor risk factor was the anatomical extent of disease. this correlation may be explained by major surgical contamination or manipulation as well as by lower immunological host reaction, all related to the extent of the tumor. A lower immunological defense could also explain the worse outcome for patients with Stage II or III lung cancer in whom empyema developed postoperatively.

Successful validation of the palliative prognostic score in terminally ill cancer patients. Italian Multicenter Study Group on Palliative Care.

The aim of this work was to validate a previously constructed prognostic score for terminally ill cancer patients in order to determine its value in clinical practice. The Palliative Prognostic Score (PaP Score) was tested on a population of 451 evaluable patients consecutively entered in the hospice programs of 14 Italian Palliative Care Centers. The score subdivided patients into three specific risk classes based on the following six predictive factors of death: dyspnea, anorexia, Karnofsky Performance Status (KPS), Clinical Prediction of Survival (CPS), total white blood count (WBC), and lymphocyte percentage. The performance of the PaP Score index in the training and testing sets was evaluated by comparing mortality rates in the 3 prognostic risk categories. The score was able to subdivide the validation-independent case series into three risk groups. Median survival was 76 days in group A (with a 86.6% probability of 30-day survival), 32 days in group B (with a 51.6% probability of 30-day survival), and 14 days in group C (with a 16.9% probability of 30-day survival). Survival medians were remarkably similar to those of the training set (64 days in group A, 32 days in group B, and 11 days in group C). In the complex process of staging terminally ill patients, the PaP Score is a simple instrument which permits a more accurate quantification of expected survival. It has been validated on an independent case series and is thus suitable for use in clinical practice.

Detection of cardiac arrhythmias and ischaemic events in combination chemotherapy with cisplatin, etoposide and bleomycin for testicular cancer.

Ten patients treated with combination chemotherapy regimen containing Cisplatin, Bleomycin and Etoposide (PEB) were submitted to Holter monitoring during the first cycle of treatment. No modifications of heart rate, ST-T segment were observed and only a slight increase of incidence of sopraventricular ectopic beats was recorded. One patient developed a transient second degree atrio-ventricular block in the first day during episodes of vomiting. These data suggest that combination chemotherapy with PEB, at least during the first cycle of treatment, has no significant arrhythmogenic effect.

Prognosis and treatment of loco-regional breast cancer recurrences: critical considerations on 120 cases.

In the present study we report the long-term results for 120 female patients who underwent mastectomy for breast cancer, from 1955 to 1965, and in whom the first relapse was represented by a skin recurrence or a supraclavicular lymph node metastasis. Eighty-nine patients had been submitted only to local therapy, 11 had also undergone bilateral oophorectomy, and in the remaining 20 hormonal compounds had been administered in addition to local therapy. The disease-free interval between the first and the second relapse, and survival after the treatment of the first relapse were strictly related to the presence and the number of axillary lymph node metastases at the time of the mastectomy (N category). In fact, the median survival was 19.5 months for 63 cases with more than 3 metastatic lymph nodes, 29 months for 24 cases with 1-3 involved lymph nodes, and 59 months for 38 cases without axillary involvement. No significant difference in survival was observed in relation to chronological age and menopausal status of the patients or to the length of the disease-free interval. The association of endocrine therapies to local treatment of the recurrences also did not increase the survival rate in these cases. The present data indicate that the prognosis for patients with recurrent breast cancer is mainly related to the N category.

Post-thoracotomy diagnostic and staging conversion rates of clinically staged I lung cancer.

The accuracy of stage I lung cancer assessment achieved by traditional clinico-diagnostic staging was retrospectively evaluated in 164 consecutive patients who underwent thoracotomy. The diagnostic conversion rate was 6.7% (1 carcinoid and 10 innocent pulmonary lesions) and occurred only in the subset of patients lacking preoperative pathologic confirmation (15%). The conversion rate to unresectable tumor extent was 8% (11/153), and local spread was the main cause of unresectability (5.5%). The staging conversion rate was 29% (43/153): the conversion rate for nodal evaluation was double that of primary tumor evaluation (24% versus 12%), but conversion to anatomically unresectable nodal diffusion occurred in only one patient (0.6%). The ability of the surgeon to convert the wrong diagnosis was scanty without extemporary biopsy, and 7 patients with innocent lesions underwent standard resection for primary cancer. Surgical staging was a precise as pathological staging in primary tumor evaluation, but was faulty in nodal evaluation (15% error in sN- and sN1-2 assessment). It is concluded that following stage I lung cancer assessment by traditional means, supplementary examinations are requested for a better sensitivity of pathological confirmation and a better refinement of local spread. Better nodal evaluation has less value until a biologic limit to surgery for anatomically resectable nodal diffusion is universally accepted.

Hormone treatment and sex steroid receptors in metastatic renal cell carcinoma: report of a multicentric prospective study.

Twenty-eight patients with metastatic renal cell carcinoma entered a multicentric prospective study to evaluate the response to high-dose medroxyprogesterone acetate (MPA) and testosterone in MPA failures in relation to sex steroid receptors. No objective remission was seen in the 24 evaluable patients, and only disease stabilizations of short duration were achieved in one-third of treated patients. Stabilizations achieved with second line testosterone were all seen in patients unresponsive to MPA. Receptor studies demonstrated that estrogen, progesterone, or androgen receptors were found in low concentrations and in only 6 of 23 tumors (26%) and 13 normal tissue samples (56%). Surprisingly, no disease stabilization was achieved in patients positive for receptors. It can be concluded that the occasional objective responses to hormone therapy reported in the literature may have been due to some cytotoxic effect of hormone therapy rather than to a true hormonal mechanism.

Pulmonary carcinoid tumors: report on 19 cases.

Nineteen cases of pulmonary carcinoid tumors, three of which showed clinically malignant behavior, are reported. The diagnostic and therapeutic possibilities are discussed. Diagnosis is sometimes possible on radiologic examination, when the clinical behavior is not yet malignant. However, these tumors are frequently mistaken for malignant heteroplasias, during the diagnostic work-up so that the postoperative histologic examination results are sometimes surprising. The clinical postoperative course is favorable in the majority of cases, and in the eight cases, we were able to follow up for more than five years, there was only one recurrence. Although pulmonary carcinoids are histologically similar to intestinal carcinoids, and like the latter are abundantly vascularized, they are only rarely accompanied by the carcinoid syndrome, which is often observed in the intestinal form.

[Treatment of lymphatic metastasis of squamous cell carcinoma of the penis: experience at the National Tumor Institute of Milan]. / Trattamento delle metastasi linfonodali da carcinoma spinocellulare del pene: l'esperienza dell'Istituto Nazionale tumori di Milano.

Between 1964 and 1990 inclusive, 204 consecutive naive patients with penile cancer and 14 patients with recurrence in the inguinal nodes have been referred at INT, Milano. Nodal metastases occurred in 100% of category T3, T4 patients, in 82% T2, in 60% G2-3 T1 and only in 16.5% of G1 T1. Out of the 47 patients who had primary ileoinguinal lymphadenectomy, 16 (34%) had negative nodes, versus 100% metastases in the 25 patients operated during the follow-up. The relapse rate was 45% in the 31 patients treated only surgically in the 1964-77 period, versus 16% in the 25 cases submitted to adjuvant chemotherapy between 1978 and 1990. All 4 relapses in the adjuvant treatment group occurred in the 8 patients with bilateral metastases. Twenty-six patients had fixed inguinal nodes: the first 10 were treated with radiotherapy, with or without methotrexate or bleomycin, and the last 16 have been submitted to neoadjuvant chemotherapy. Only one patient of the first group could be operated and all 10 died of cancer within 3 years. On the contrary, 9 (56%) of the 16 patients treated with neoadjuvant chemotherapy could undergo subsequent surgery and 5 (31%) are alive disease free since over 5 years. Prophylactic lymphadenectomy may be indicated in all T2, T3, T4 patients and in indifferentiated T1 tumors. Adjuvant and neoadjuvant chemotherapy can improve the results of radical surgery, significantly.

[Interferon and vinblastine in presumably operable metastases of renal carcinoma]. / Interferone e vinblastina nelle metastasi presumibilmente operabili da carcinoma renale.

From January 1987 to December 1990, 14 consecutive patients with resectable metastases from renal cell carcinoma, underwent 3 cycles of preoperative alpha-2a Interferon (INF), 18 MUI s.c. 3 times a week, and Vinblastine (VLB), 0.15 mg/kg on day 1, every 21, days. Out of the 13 patients who completed the treatment, 4 (30.7%) achieved a clinical response (1 CR and 3 PR). Nine (69.3%) patients were submitted to surgery: all, including the CRer, had residual cancer and only 4 were radically resected. The latter were further submitted to 3 INF and VLB cycles: 2 relapsed after 7 and respectively 30 months, whilst 2 (15.4%) are alive disease-free at 12 and 52 months respectively.

[Adjuvant interferon alpha in renal carcinoma with a high risk of recurrence. Multicenter pilot study]. / Alfa-interferone adiuvante nel carcinoma renale ad alto rischio di ricaduta. Studio pilota multicentrico.

Twenty-eight consecutive patients submitted to radical nephrectomy for Robson's stage II-III renal cell carcinoma underwent adjuvant recombinant a-2b interferon, 5 MUI s.c. 3 times a week, for 6 consecutive months. Home-feasibility of this therapy resulted easy. The most frequent acute (flu-like syndrome) and late (myalgia, fatigue, anorexia) side effects did not affect normal daily life of patients. Eight (28.5%) patients had WHO grade < or = 2 biochemical and hematological toxicity, that normalized after a reduction or a temporarily suspension of therapy. Twenty-seven patients were evaluable for response. Out of these, 7 (26%) relapsed after a 16 months median follow-up.

[Therapeutic alternatives in the treatment of class T1N0 squamous cell carcinoma of the penis: indications and limitations]. / Alternative terapeutiche nel trattamento del carcinoma spinocellulare del pene di categoria T1N0: indicazioni e limiti.

At INT of Milan between 1964 and 1990, 204 consecutive native patients suffering from penile cancer have been treated. 101 (59%) patients out of 171 with invasive cancer (23 affected with Tis were excluded) have been classified T1N0M0. 74 patients have been treated with penis conserving methods, such as circumcision, radiotherapy, laser excision and primary chemotherapy + conserving surgery. Overall local failure and/or nodal relapses occurred in 27% (20/74). Relapses are significantly related with grading but there isn't any relationship with macroscopical aspect or size of the tumor. The conservative treatment had been possible in 80% of patients. In our experience T1N0 clinical stage conservative therapy does not worsen the prognosis.