We did consider and offer the patient a more conservative trial of observation for possible resolution.
Recently, we performed a trial of observation without surgical treatment for papillary microcarcinoma patients, and found that most of these tumours do not enlarge, indicating that these lesions do not grow or grow only slowly (Ito et al, 2003).
In the ESPAC-1 trial of observation, chemotherapy (bolus 5-FU) and chemoradiotherapy in 549 patients with resected pancreatic cancer, there was an improvement in survival for the chemotherapy but not the chemoradiotherapy arms.
Based on this hypothesis and the preclinical data related to extreme sensitivity to oestrogen after disease progression on AI therapy and because of the short half-lives of AIs (Guerrieri-Gonzaga et al, 2001; Buzdar et al, 2002), and supported by the abrupt resolution of AI-induced vasomotor symptoms, we conducted a prospective phase II clinical trial of observation after AI withdrawal for MBC.
A randomized trial of observation versus oophorectomy plus tamoxifen in 709 premenopausal Vietnamese and Chinese women (#99) reported substantial improvements in disease-free survival (75% versus 58%; P = 0.006) and overall survival (78% versus 70%; P = 0.04; 80% versus 58% among ER-positive patients) for the endocrine therapy.
The methods for conducting the measurement included numerous trials for observation of an accidental event (ie, tripping).
We therefore restricted investigations in the first part of the trial to observation and laboratory tests from sera that have been obtained for routine diagnostics independently from this study, therefore not requiring extra-specimens.
The first trial of each observation block was modeled by a separate regressor.
The observation that chemotherapy is most effective when the tumor volume is small and cancer cells are in the linear growth phase led to the initial randomized controlled trials of polychemotherapy versus observation in patients with lymph node-positive breast cancer.
Indeed, adjuvant therapeutic efficacy can currently be assessed only in large-scale clinical trials after observation periods of several years.
Although the main use of HRQoL instruments has been in the context of clinical trials, the observation that measures of patients' perception of their health do not overlap with clinician assessments of disability reinforces the importance of developing HRQoL instruments for use in routine clinical practice [ 14, 15].
