Virtual Multidisciplinary Tumor Boards: A Narrative Review Focused on Lung Cancer.

To date, the virtual multidisciplinary tumor boards (vMTBs) are increasingly used to achieve high-quality treatment recommendations across health-care regions, which expands and develops the local MTB team to a regional or national expert network. This review describes the process of lung cancer-specific MTBs and the transition process from face-to-face tumor boards to virtual ones. The review also focuses on the project organization's description, advantages, and disadvantages. Semi-structured interviews identified five major themes for MTBs: current practice, attitudes, enablers, barriers, and benefits for the MTB. MTB teams exhibited positive responses to modeled data feedback. Virtualization reduces time spent for travel, allowing easier and timely patient discussions. This process requires a secure web platform to assure the respect of patients' privacy and presents the same unanswered problems. The implementation of vMTB also permits the implementation of networks especially in areas with geographical barriers facilitating interaction between large referral cancer centers and tertiary or community hospitals as well as easier access to clinical trial opportunities. Studies aimed to improve preparations, structure, and conduct of MTBs, research methods to monitor their performance, teamwork, and outcomes are also outlined in this article. Analysis of literature shows that MTB participants discuss 5-8 cases per meeting and that the use of a vMTB for lung cancer and in particular stage III NSCLC and complex stage IV cases is widely accepted by most health professionals. Despite still-existing gaps, overall vMTB represents a unique opportunity to optimize patient management in a patient-centered approach.

Long-Term Follow-up Results of the DANTE Trial, a Randomized Study of Lung Cancer Screening with Spiral Computed Tomography.

RATIONALE: Screening for lung cancer with low-dose spiral computed tomography (LDCT) has been shown to reduce lung cancer mortality by 20% compared with screening with chest X-ray (CXR) in the National Lung Screening Trial, but uncertainty remains concerning the efficacy of LDCT screening in a community setting. OBJECTIVES: To explore the effect of LDCT screening on lung cancer mortality compared with no screening. Secondary endpoints included incidence, stage, and resectability rates. METHODS: Male smokers of 20+ pack-years, aged 60 to 74 years, underwent a baseline CXR and sputum cytology examination and received five screening rounds with LDCT or a yearly clinical review only in a randomized fashion. MEASUREMENTS AND MAIN RESULTS: A total of 1,264 subjects were enrolled in the LDCT arm and 1,186 in the control arm. Their median age was 64.0 years (interquartile range, 5), and median smoking exposure was 45.0 pack-years. The median follow-up was 8.35 years. One hundred four patients (8.23%) were diagnosed with lung cancer in the screening arm (66 by CT), 47 of whom (3.71%) had stage I disease; 72 control patients (6.07%) were diagnosed with lung cancer, with 16 (1.35%) being stage I cases. Lung cancer mortality was 543 per 100,000 person-years (95% confidence interval, 413-700) in the LDCT arm versus 544 per 100,000 person-years (95% CI, 410-709) in the control arm (hazard ratio, 0.993; 95% confidence interval, 0.688-1.433). CONCLUSIONS: Because of its limited statistical power, the results of the DANTE (Detection And screening of early lung cancer with Novel imaging TEchnology) trial do not allow us to make a definitive statement about the efficacy of LDCT screening. However, they underline the importance of obtaining additional data from randomized trials with intervention-free reference arms before the implementation of population screening.

Surgical procedures in the DANTE trial, a randomized study of lung cancer early detection with spiral computed tomography: comparative analysis in the screening and control arm.

BACKGROUND: The patient population derived from lung cancer screening programs with low-dose spiral computed tomography (LDCT) is different from the general population accessing thoracic surgical services. METHODS: Retrospective review of all surgical cases in the DANTE trial, a randomized study of lung cancer screening with LDCT. Patient characteristics, workup, procedures, resections for benign disease, complications, tumor features, and final outcomes have been analyzed in the LDCT and in the control arm. RESULTS: In the LDCT arm, 77 suspicious lesions were surgically managed in 72 patients. A benign lesion was diagnosed in 17 cases (22%). Major video-assisted thoracoscopic surgery resection was carried out in five lung cancer cases (7%) and segmentectomy in 11 (19%). Complete resection was achieved in 93%, and stage I rate was 73%. Two patients had a local recurrence after open lobectomy, and three had a resectable new primary. In the control group, 28 patients underwent 31 surgical procedures, in five cases (16%) for benign lesions. No major video-assisted thoracoscopic surgery resections were carried out. Resectability rate was 88%, and stage I rate was 52%. Five patients had a local recurrence and two had a second primary. CONCLUSIONS: Surgery for benign lesions is a relevant issue in screening-derived patients. Local control may be achieved by minimally invasive techniques or segmentectomy; however, developing the necessary skills requires an effort by the surgical team. Long-term survivors have a noticeable chance of developing second primary cancers or resectable recurrences and may benefit from a second resection.

A randomized study of lung cancer screening with spiral computed tomography: three-year results from the DANTE trial.

RATIONALE: Screening for lung cancer with modern imaging technology may decrease lung cancer mortality, but encouraging results have only been obtained in uncontrolled studies. OBJECTIVES: To explore the effect of screening with low-dose spiral computed tomography (LDCT) on lung cancer mortality. Secondary endpoints are incidence, stage at diagnosis, and resectability. METHODS: Male subjects, aged 60 to 75 years, smokers of 20 or more pack-years, were randomized to screening with LDCT or control groups. All participants underwent a baseline, once-only chest X-ray and sputum cytology examination. Screening-arm subjects had LDCT upon accrual to be repeated every year for 4 years, whereas controls had a yearly medical examination only. MEASUREMENTS AND MAIN RESULTS: A total of 2,811 subjects were randomized and 2,472 were enrolled (LDCT, 1,276; control, 1,196). After a median follow-up of 33 months, lung cancer was detected in 60 (4.7%) patients receiving LDCT and 34 (2.8%) control subjects (P = 0.016). Resectability rates were similar in both groups. More patients with stage I disease were detected by LDCT (54 vs. 34%; P = 0.06) and fewer cases were detected in the screening arm due to intercurrent symptoms. However, the number of advanced lung cancer cases was the same as in the control arm. Twenty patients in the LDCT group (1.6%) and 20 controls (1.7%) died of lung cancer, whereas 26 and 25 died of other causes, respectively. CONCLUSIONS: The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated.

Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial.

BACKGROUND: Despite the high survival rates reported for screening-detected cases, the potential of screening of high-risk subjects for reducing lung cancer mortality is still unproven. We herewith present the baseline results of a randomized trial comparing screening for lung cancer with annual spiral computed tomography (CT) versus a yearly clinical review. METHODS: Male subjects, 60-74 years old, and smokers of 20+ pack-years were enrolled. All participants received a baseline medical examination, chest X-rays (CXR) and sputum cytology upon accrual. Subjects randomized in the spiral CT group received a spiral CT scan at baseline, then yearly for the following 4 years. For controls, a yearly clinical examination was scheduled for the following 4 years. RESULTS: 2472 subjects were randomized (1276 spiral CT arm, 1196 controls). Age, smoking exposure and co-morbid conditions were similar in the two groups. In the spiral CT group, 28 lung cancers were detected, 13 of which were visible in the baseline chest X-rays (overall prevalence 2.2%). Sixteen out of 28 tumours (57%) were stage I, and 19 (68%) were resectable. In the control group, eight cases were detected by the baseline chest X-rays (prevalence rate 0.67%), four (50%) were stage I, and six (75%) were resectable. CONCLUSIONS: Baseline lung cancer detection rate in the spiral CT arm was higher than in most published studies. The stage I detection rate was increased four-fold by spiral CT versus chest X-rays. However, more tumours in an advanced stage were also detected by CT. The high resection rate of screening-detected patients suggests a possible increase in cure rate. However, longer follow-up is required for definitive conclusions. This trial has been registered at www.Clinicaltrials.gov, registration No. NCT00420862.

Vinorelbine and 5-fluorouracil bolus and/or continuous venous infusion plus levofolinic acid as second-line chemotherapy for metastatic breast cancer: an analysis of results in clinical practice of the Gruppo Oncologico Italia Meridionale (GOIM).

BACKGROUND: This retrospective study evaluated the activity and toxicity profile of a regimen of vinorelbine and 5-fluorouracil with levofolinic acid, given to a large series of patients with recurrent or refractory metastatic breast cancer after first-line chemotherapy. PATIENTS AND METHODS: Overall, 286 evaluable patients were included in the analysis. Two chemotherapy schedules were reviewed: a) the bolus regimen consisted of levofolinic acid 100 mg/m2 and 5-fluorouracil 375 mg/m2, both administered i.v. on days 1,2 and 3, plus vinorelbine 25 mg/m2 i.v. bolus on days 1 and 8 every 3 weeks; b) the infusional regimen of levofolinic acid 100 mg/m2 given as a 2-hour infusion, followed by 5-fluorouracil 400 mg/m2 i.v. bolus and by 5-fluorouracil 600 mg/m2 administered as 22-hour continuous venous infusion (c.v.i) for 2 days, plus vinorelbine i.v. bolus on days 1 and 8. RESULTS: Overall, twelve patients achieved a complete response (4%; 95%CL 2%-7%) and 115 patients showed a partial response (40%, 95%CL 34%-46%), for an overall response rate of 44% (95CL 39%-50%). Sixty-one patients had stable disease (21%) and 98 patients progressive disease (34%). The tumor growth control rate was 63% (95%CL 60%-71%). Patients with soft tissue metastases as the dominant disease showed the highest response rate (56%), followed by viscera (48%) and bone (33%). The difference in response rate between patients with dominant visceral disease versus those with dominant bone disease was statistically significant (p=0.038). Patients treated with the bolus schedule achieved a 40% overall response rate with a 5% complete response rate, while those who received the infusional regimen had a 48% overall response rate with a 5% complete response rate. This difference was not statistically significant (p=0.164). The overall median duration of objective responses was 8.3 months (range 4-14 months), median time to progression of the all series was 6.1 months (range 2-24 months) and the median overall survival was 14.6 months (range 3-32). There was a statistically significant difference in survival among responder and non-responder patients (p=0.0009). CONCLUSION: The results of this large off-trial analysis confirmed the clinical activity and adverse-event profile reported in controlled clinical trials of the vinorelbine/ 5-fluorouracil with levofolinic acid regimen in clinical practice. This combination regimen was active with a low toxicity burden and, therefore, represents a good therapeutic choice for patients who require second-line chemotherapy.

Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale.

PURPOSE: We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. PATIENTS AND METHODS: A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m(2) on day 1 with LV 100 mg/m(2) administered as a 2-hour infusion before FU 400 mg/m(2) administered as an intravenous bolus injection, and FU 600 mg/m(2) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m(2) on day 1 with LV5FU2 regimen). RESULTS: One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. CONCLUSION: There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

Vinorelbine and cisplatin for the treatment of recurrent and/or metastatic carcinoma of the uterine cervix.

BACKGROUND: To test the clinical activity and toxicity profile of the combination regimen of vinorelbine and cisplatin in a series of patients with carcinoma of the cervix uteri with de novo metastatic disease or recurrent disease after previous therapy. The main aims of the study included analysis of objective response rates, toxicity, and time to progression. PATIENTS AND METHODS: Forty-two eligible patients were enrolled into the trial and treated with cisplatin 80 mg/m(2) on day 1 and vinorelbine 25 mg/m(2) on day 1 and 8. This regimen was repeated every 21 days upon resolution of toxicity for 3 cycles before response assessment. Enrolled patients had a median age of 53 years, a median ECOG performance status of 1, and mostly a squamous cell histology (86%). Sixteen patients (38%) were treatment-naive since first diagnosed with widespread metastatic disease, 7% had only previous surgery, 31% radiotherapy, and 24% both radiation and surgical therapy. In previously radiated patients, 21% of patients had disease only within the radiation fields, 21% only outside the radiation fields, and 12% both inside and outside the radiotherapy portals. RESULTS: All patients were evaluable for response analysis. A complete response was achieved in 5 patients (12%), and a partial response in 15 cases (36%) for an overall response rate of 48% (95% CL 22-52%). Patients with recurrent disease within the previous radiation field (including those also with disease outside the radiation fields) showed a 28% overall response rate with no complete response, while patients with disease previously untreated with radiotherapy or with tumour deposits only outside of ratiation portals yielded a 57% overall response rate with a 18% complete response rate. Only 1 out of 8 patients with performance status 2 showed a major response (12%). Median time to progression was 5.6 months (range 2.0-14 months). The median overall survival of the whole series was 9.1 months. Hematological toxicity was the most frequent side-effect. Grade 3 vomiting was recorded in 9 patients (21%), and mild mucositis in 14% of patients. Grade 3 neutropenia was observed in 21% of patients, while grade 4 in 12% of cases with neutropenic fever was seen in 4 cases. Sixteen patients (38%) complained of grade 1-2 constipation, while grade 1-2 peripheral neuropathy was seen in 8 patients (19%). CONCLUSIONS: The results achieved in this trial suggest that the combination regimen of vinorelbine and cisplatin may be safely given to patients with metastatic and/or recurrent carcinoma of the uterine cervix. This regimen is active at least in terms of objective response rates. Although satisfactory results are still lacking, these results suggest that the vinorelbine-cisplatin regimen is worthy of further studies and may represent the basis for the development of new active regimens.