Primary infusional ECF appears to be more active on clinical and histopathologic grounds than conventional chemotherapy for large operable breast cancer and is well tolerated. This approach now merits randomized comparison to determine if high CR rates may translate into improved survival.
Infusional ECF is a highly active regimen in advanced breast cancer and warrants evaluation in high-risk early breast cancer.
Surgery offers the best chance of cure for patients with NSCLC, although no more than 20% are operable. Overall surgical 5-year survival rates are 55% for stage I, 25% for stage II, and 20% for stage III disease (Mountain, 1977); patients with completely resected T3 tumours without mediastinal node involvement have a slightly better outlook with approximately 40% 5-year survival (McCormack et al, 1987). These results can at best be described as moderate and it is likely that many surgical patients would accept the option of additional treatment to try to improve their outlook (Slevin et al, 1990).Randomized trials of post-operative adjuvant chemotherapy in NSCLC have shown some prolongation of disease-free survival with cisplatin-containing schedules (Holmes et al, 1986;Lad et al, 1988;Niiranen et al, 1992). A meta-analysis of eight such trials has shown a 13% reduction in the risk of death, corresponding to an absolute survival benefit of around 5% at 5 years (Non-small Cell Lung Cancer Collaborative Group, 1995). A value judgement is required on the clinical benefit of such treatment, and it seems unlikely that significant further progress will be made with postoperative therapy using currently available drugs.Pre-operative chemotherapy is currently being investigated in several tumour types including NSCLC, breast cancer and gastric cancer. In NSCLC, most pre-operative chemotherapy studies have been carried out in patients with stage IIIA disease. In nonrandomized studies, response rates have ranged from 50% to 75% with occasional (10%) complete remissions; subsequent resectability rates of 65-90% and 3-5-year survival rates of 17-40% have been reported (Faber et al, 1989;Skarin et al, 1989;Weiden et al, 1991;Burkes et al, 1992;Strauss et al, 1992;Martini et al, 1993). The heterogeneity of entry criteria and the lack of data from randomized trials make these results difficult to interpret, but they make the important point that the majority of such patients appear to have chemosensitive disease prior to surgery. Two small randomized trials have compared surgery with or without preoperative chemotherapy in patients with stage IIIA disease, each with similar and strikingly positive results in favour of chemotherapy. In the first study, median survival was 26 months for patients treated with pre-operative chemotherapy, compared with 8 months for patients treated with surgery alone (Rosell et al, 1994). The second study reported respective median survivals of 64 months vs 11 months (Roth et al, 1994).These results, although encouraging, must be interpreted with caution because of the small number of patients randomized. They emphasize the need for a large multi-centre randomized trial, and we felt that this should involve all patients with operable lung cancer. Such an approach is novel and is associated with several uncertainties. These include the question of acceptability of preoperative chemotherapy to both patient and doctor, the potential for unacceptable chemotherapy-induced toxicity prior to surgery, and...
ImportanceAmyloid positron emission tomography (PET) allows the direct assessment of amyloid deposition, one of the main hallmarks of Alzheimer disease. However, this technique is currently not widely reimbursed because of the lack of appropriately designed studies demonstrating its clinical effect.ObjectiveTo assess the clinical effect of amyloid PET in memory clinic patients.Design, Setting, and ParticipantsThe AMYPAD-DPMS is a prospective randomized clinical trial in 8 European memory clinics. Participants were allocated (using a minimization method) to 3 study groups based on the performance of amyloid PET: arm 1, early in the diagnostic workup (within 1 month); arm 2, late in the diagnostic workup (after a mean [SD] 8 [2] months); or arm 3, if and when the managing physician chose. Participants were patients with subjective cognitive decline plus (SCD+; SCD plus clinical features increasing the likelihood of preclinical Alzheimer disease), mild cognitive impairment (MCI), or dementia; they were assessed at baseline and after 3 months. Recruitment took place between April 16, 2018, and October 30, 2020. Data analysis was performed from July 2022 to January 2023.InterventionAmyloid PET.Main Outcome and MeasureThe main outcome was the difference between arm 1 and arm 2 in the proportion of participants receiving an etiological diagnosis with a very high confidence (ie, ≥90% on a 50%-100% visual numeric scale) after 3 months.ResultsA total of 844 participants were screened, and 840 were enrolled (291 in arm 1, 271 in arm 2, 278 in arm 3). Baseline and 3-month visit data were available for 272 participants in arm 1 and 260 in arm 2 (median [IQR] age: 71 [65-77] and 71 [65-77] years; 150/272 male [55%] and 135/260 male [52%]; 122/272 female [45%] and 125/260 female [48%]; median [IQR] education: 12 [10-15] and 13 [10-16] years, respectively). After 3 months, 109 of 272 participants (40%) in arm 1 had a diagnosis with very high confidence vs 30 of 260 (11%) in arm 2 (P < .001). This was consistent across cognitive stages (SCD+: 25/84 [30%] vs 5/78 [6%]; P < .001; MCI: 45/108 [42%] vs 9/102 [9%]; P < .001; dementia: 39/80 [49%] vs 16/80 [20%]; P < .001).Conclusion and RelevanceIn this study, early amyloid PET allowed memory clinic patients to receive an etiological diagnosis with very high confidence after only 3 months compared with patients who had not undergone amyloid PET. These findings support the implementation of amyloid PET early in the diagnostic workup of memory clinic patients.Trial RegistrationEudraCT Number: 2017-002527-21
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