[Value-based cancer care. From traditional evidence-based decision making to balanced decision making within frameworks of shared values]. / La decisione oncologica basata sui valori Dal tradizionale processo decisionale oncologico evidence-based a scelte basate su valori bilanciati e condivisi.

Clinical decision making in oncology is based so far on the evidence of efficacy from high-quality clinical research. Data collection and analysis from experimental studies provide valuable insight into response rates and progression-free or overall survival. Data processing generates valuable information for medical professionals involved in cancer patient care, enabling them to make objective and unbiased choices. The increased attention of many scientific associations toward a more rational resource consumption in clinical decision making is mirrored in the Choosing Wisely campaign against the overuse or misuse of exams and procedures of little or no benefit for the patient. This cultural movement has been actively promoting care solutions based on the concept of "value". As a result, the value-based decision-making process for cancer care should not be dissociated from economic sustainability and from ethics of the affordability, also given the growing average cost of the most recent cancer drugs. In support of this orientation, the National Comprehensive Cancer Network (NCCN) has developed innovative and "complex" guidelines based on values, defined as "evidence blocks", with the aim of assisting the medical community in making overall sustainable choices.

Advanced adult esthesioneuroblastoma successfully treated with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine.

The esthesioneuroblastoma is a rare neuroendocrine tumor that derives from the olfactory cells. In the last 20 years, around 1,000 cases have been described, with an overall survival rate of 60-70% at 5 years. The most common symptoms are nasal bleeding, nasal clogging and, in locally advanced cases, signs/symptoms of intracranic hypertension such as papilla edema, cefalea, and vomiting. The standard treatments are surgery and radiotherapy. Chemotherapy can be used in an adjuvant/neoadjuvant setting and in the metastatic phase, even if its role is still not established with certainty. Here, the case is reported of a young man (38 years old) with a locally advanced esthesioneuroblastoma. Two months before coming to our clinic, he had been treated elsewhere with debulking surgery through bilateral frontal craniotomy. After surgery, MRI showed residual disease in the nasal cavities and in the medial wall of the orbits responsible for blindness and bilateral exophthalmos within a month: a very short time. Octreoscan and whole body CT scan confirmed a locally advanced disease, in the absence of metastases. Chemotherapy was begun with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine with granulocyte colony-stimulating factor (G-CSF) support after every cycle. Soon after the first cycle, an important reduction of pain and decrease of the exophthalmos and vertigos was observed. No improvement in blindness was seen. The patient is still stable after 24 months of follow up.

Residual neurotoxicity in ovarian cancer patients in clinical remission after first-line chemotherapy with carboplatin and paclitaxel: the Multicenter Italian Trial in Ovarian cancer (MITO-4) retrospective study.

BACKGROUND: Carboplatin/paclitaxel is the chemotherapy of choice for advanced ovarian cancer, both in first line and in platinum-sensitive recurrence. Although a significant proportion of patients have some neurotoxicity during treatment, the long-term outcome of chemotherapy-induced neuropathy has been scantly studied. We retrospectively assessed the prevalence of residual neuropathy in a cohort of patients in clinical remission after first-line carboplatin/paclitaxel for advanced ovarian cancer. METHODS: 120 patients have been included in this study (101 participating in a multicentre phase III trial evaluating the efficacy of consolidation treatment with topotecan, and 19 treated at the National Cancer Institute of Naples after the end of the trial). All patients received carboplatin (AUC 5) plus paclitaxel (175 mg/m2) every 3 weeks for 6 cycles, completing treatment between 1998 and 2003. Data were collected between May and September 2004. Residual sensory and motor neurotoxicity were coded according to the National Cancer Institute--Common Toxicity Criteria. RESULTS: 55 patients (46%) did not experience any grade of neurological toxicity during chemotherapy and of these none had signs of neuropathy during follow-up. The other 65 patients (54%) had chemotherapy-induced neurotoxicity during treatment and follow-up data are available for 60 of them. Fourteen out of 60 patients (23%) referred residual neuropathy at the most recent follow-up visit, after a median follow up of 18 months (range, 7-58 months): 12 patients had grade 1 and 2 patients grade 2 peripheral sensory neuropathy; 3 patients also had grade 1 motor neuropathy. The remaining 46/60 patients (77%) had no residual neuropathy at the moment of interview: recovery from neurotoxicity had occurred in the first 2 months after the end of chemotherapy in 22 (37%), between 2 and 6 months in 15 (25%), or after more than 6 months in 9 patients (15%). Considering all 120 treated patients, there was a 15% probability of persistent neurological toxicity 6 months after the end of chemotherapy. CONCLUSION: A significant proportion of patients with advanced ovarian cancer treated with first-line carboplatin/paclitaxel suffer long-term residual neuropathy. This issue should be carefully taken into account before considering re-treatment with the same agents in sensitive recurrent disease.

Topotecan compared with no therapy after response to surgery and carboplatin/paclitaxel in patients with ovarian cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) randomized study.

PURPOSE: Topotecan is an active second-line treatment for advanced ovarian cancer. Its efficacy as consolidation treatment after first-line standard chemotherapy is unknown. PATIENTS AND METHODS: To investigate whether topotecan (1.5 mg/m(2) on days 1 through 5, four cycles, every 3 weeks) prolonged progression-free survival (PFS) for patients responding to standard carboplatin (area under the curve 5) and paclitaxel (175 mg/m(2) administered as a 3-hour infusion in six cycles; CP), a multicenter phase III study was performed with an 80% power to detect a 50% prolongation of median PFS. Patients were registered at diagnosis and randomized after the end of CP. RESULTS: Two hundred seventy-three patients were randomly assigned (topotecan, n = 137; observation, n = 136), with a median age of 56 years. Stage at diagnosis was advanced in three fourths of patients (stage III in 65% of patients; stage IV in 10%); after primary surgery, 46% had no residual disease and 20% were optimally debulked. After CP, 87% reached a clinical complete response, and 13% achieved a partial response. Neutropenia (grade 3/4 in 58% of the patients) and thrombocytopenia (grade 3 in 21%; grade 4 in 3%) were the most frequent toxicities attributed to topotecan. There was no statistically significant difference in PFS between the arms (P =.83; log-rank test): median PFS was 18.2 months in the topotecan arm and 28.4 in the control arm. Hazard ratio of progression for patients receiving topotecan was 1.18 (95% CI, 0.86 to 1.63) after adjustment for residual disease, interval debulking surgery, and response to CP. CONCLUSION: The present analysis indicates that consolidation with topotecan does not improve PFS for patients with advanced ovarian cancer who respond to initial chemotherapy with carboplatin and paclitaxel.

de Gramont schedule is a very low toxic and effective regimen in low performance status patients affected by metastatic gastric cancer: preliminary report.

UNLABELLED: Treatment of patients affected by metastatic gastric cancer with low performance status (PS) is a very hard choice. It is mandatory to define a very well-tolerated schedule to be employed in these subgroup of patients. PATIENTS AND METHODS: From June 1999 to December 2001, 21 patients (pts) affected by metastatic gastric cancer with low performance status (> or = 2 ECOG) were treated with bimonthly "de Gramont" schedule. Treatment was planned to perform 6 courses of chemotherapy for each patient plus other 2-4 if a response had been documented. RESULTS: A total of 161 courses of de Gramont schedule was administered to the 21 pts enrolled. We observed 8 PD (38%), 8 SD (38%), 5 objective responses (24%--2 MR, 3 PR). Duration of objective responses (OR) was 5 months, 3 months for 3 PRs and 2 and 1 months for two MRs respectively. At time of observation (June 2002) median overall survival (OS) was 14 months, median survival from the starting de Gramont schedule was 8 months. Toxicity was very mild: grade 3 leukopenia in 1 pt, grade 1-2 anemia and piastrinopenia in 3 pts, grade 1-2 nausea vomiting in 5 pts, grade 1 diarrhea in 4 pts, grade 3 mucositis in 2 pts. No other side effect was renowned. PS ameliorated in 12 (57%) pts, even if a major response was not noted. CONCLUSIONS: de Gramont schedule can be safely and effectively employed in metastatic gastric cancer pts with very low performance status.