A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These ...unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer.
MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol.
We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data.
Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.
Abstract Objectives Identification of variables predicting positive surgical margins (PSMs) in patients undergoing laparoscopic radical prostatectomy (LRP) for clinically localized prostate cancer is ...lacking. Our objective was to determine preoperative risk factors and the association of ipsilateral degree of neurovascular bundle dissection (intraoperative factor) with side-specific PSMs in these patients. Material and methods Between October 2002 and April 2005, one surgeon performed LRP on 407 previously untreated patients. Of 814 evaluable prostate sides, 728 harboured prostate cancer in the specimen and composed the study population. For each prostate side, we obtained clinical stage, biopsy Gleason, maximum percentage of tumour in the biopsy, suspected extracapsular extension (ECE) on endorectal coil magnetic resonance imaging (MRI), degree of neurovascular bundle (NVB) dissection, and PSMs. PSM was defined as cancer cells at the inked margins. Logistic regression analyses with random effects were generated. Results Of the 728 prostate sides with cancer, 51 (7%) had at least one PSM. In multivariable analysis, higher PSA ( p = 0.01), Gleason score of 7 compared with ≤6 in the biopsy ( p = 0.04), lower prostate volume on MRI ( p = 0.01), and interfascial NVB dissection compared with intrafascial dissection ( p = 0.01) were associated with an increased risk of side-specific PSMs. Suspected ECE on MRI ( p = 0.9) and clinical stage ( p = 0.3) were not significantly associated with side-specific PSMs. A subset analysis of 321 patients with bilateral tumours did not show statistically significant differences in PSMs according to tumour side ( p = 0.3). Conclusions High serum prostate-specific antigen, biopsy Gleason score of 7, low prostate volume, and interfascial NVB dissection were independently associated with side-specific PSMs after LRP, and should be considered during planning of the LRP surgical strategy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objective We sought to determine whether an acupuncture technique specially developed for a surgical oncology population (intervention) reduces pain or analgesic use after thoracotomy compared with a ...sham acupuncture technique (control). Methods One hundred sixty-two patients with cancer undergoing thoracotomy were randomized to group A (preoperative implantation of small intradermal needles that were retained for 4 weeks) or group B (preoperative placement of sham needles at the same schedule). The numeric rating scale of pain and total opioid use was evaluated during the in-patient stay, and the Brief Pain Inventory and Medication Quantification Scale were evaluated after discharge up to 3 months after the operation. Results The principal analysis, a comparison of Brief Pain Inventory pain intensity scores at the 30-day follow-up, showed no significant difference between the intervention and control groups. Pain scores were marginally higher in the intervention group (0.05; 95% confidence interval, 0.74 to −0.64; P = .9). There were also no statistically significant differences between groups for secondary end points, including chronic pain assessments at 60 and 90 days, in-patient pain, and medication use in the hospital and after discharge. Conclusion A special acupuncture technique, as provided in this study, did not reduce pain or use of pain medication after thoracotomy more than a sham technique.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Study Type – Diagnostic (exploratory cohort) Level of Evidence 2b
OBJECTIVE
• To assess variation of total prostate‐specific antigen (tPSA), free PSA (fPSA), percent fPSA, human glandular kallikrein ...2 (hK2) and intact PSA measured three times within 2 weeks. Knowledge of the variation in an individual’s PSA level is important for clinical decision‐making.
PATIENTS AND METHODS
• Study participants were 149 patients referred for prostate biopsy, of which 97 had benign disease and 52 had prostate cancer.
• Three blood samples were drawn with a median of 4 h between first and second samples and 12 days between first and third samples.
• Variability was described by absolute differences, ratios and intra‐individual coefficients of variation. Total PSA, fPSA, hK2 and intact PSA were measured in anticoagulated blood plasma.
RESULTS
• At baseline, the median tPSA was 6.8 (interquartile range, 4.5–9.6) ng/mL. The intra‐individual variation was low for all biomarkers, and lowest for tPSA. For 80% of participants, the ratio between first and second time points for tPSA was in the range 0.91–1.09 and the ratio for percent fPSA was in the range 0.89–1.15.
• Total coefficients of variation between time 1 and 2 for tPSA, fPSA, percent fPSA, hK2 and intact PSA were 4.0%, 6.6%, 6.0%, 9.2% and 9.5%, respectively.
• The measurements taken several days apart varied more than those taken on the same day, although the variation between both time points was not large.
CONCLUSIONS
• The intra‐individual variation for all the kallikrein‐like markers studied was relatively small, especially for samples drawn the same day.
• Few cases are reclassified between the time points. This indicates the high short‐term biological and technical reproducibility of the tests in clinical use.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Abstract Background Statistical prediction tools are increasingly common, but there is considerable disagreement about how they should be evaluated. Three tools—Partin tables, the European Society ...for Urological Oncology (ESUO) criteria, and the Gallina nomogram—have been proposed for the prediction of seminal vesicle invasion (SVI) in patients with clinically localized prostate cancer who are candidates for a radical prostatectomy. Objectives Using different statistical methods, we aimed to determine which of these tools should be used to predict SVI. Design, settings, and participants The independent validation cohort consisted of 2584 patients treated surgically for clinically localized prostate cancer at four North American tertiary care centers between 2002 and 2007. Interventions Robot-assisted laparoscopic radical prostatectomy. Outcome measurements and statistical analysis Primary outcome was the presence of SVI. Traditional (area under the receiver operating characteristic ROC curve, calibration plots, the Brier score, sensitivity and specificity, positive and negative predictive value) and novel (decision curve analysis and predictiveness curves) statistical methods quantified the predictive abilities of the three models. Results and limitations Traditional statistical methods (ie, ROC plots and Brier scores) could not clearly determine which one of the three SVI prediction tools should be preferred. For example, ROC plots and Brier scores seemed biased against the binary decision tool (ESUO criteria) and gave discordant results for the continuous predictions of the Partin tables and the Gallina nomogram. The results of the calibration plots were discordant with those of the ROC plots. Conversely, the decision curve indicated that the Partin tables represent the best strategy for stratifying the risk of SVI, resulting in the highest net benefit within the whole range of threshold probabilities. Conclusions When predicting SVI, surgeons should prefer the Partin tables over the ESUO criteria and the Gallina nomogram because this tool provided the highest net benefit. In contrast to traditional statistical methods, decision curve analysis gave an unambiguous result applicable to both continuous and binary models, providing an insight into clinical utility.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Racial Disparities in Low-Risk Prostate Cancer Ehdaie, Behfar; Carlsson, Sigrid; Vickers, Andrew
JAMA : the journal of the American Medical Association,
05/2019, Volume:
321, Issue:
17
Journal Article
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