Watchful Waiting after Radiochemotherapy in Rectal Cancer: When Is It Feasible?
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ABSTRACT:
SUBMITTER: Gani C
PROVIDER: S-EPMC6514498 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
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Watchful Waiting after Radiochemotherapy in Rectal Cancer: When Is It Feasible?
Gani Cihan C Kirschniak Andreas A Zips Daniel D
Visceral medicine 20190327 2
A "watch and wait" strategy in rectal cancer is increasingly considered in patients who achieve an excellent response to radiotherapy. While a growing number of studies have shown the feasibility of this strategy in selected patients, the optimal therapeutic regimen to maximize response rates still needs to be established. Furthermore, accurate response prediction and the management of minor residual findings after radiotherapy remain a matter of debate. Finally, concerns regarding the long-term ...[more]
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Project description:Radical prostatectomy reduces mortality among men with localized prostate cancer; however, important questions regarding long-term benefit remain.Between 1989 and 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012. The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy.During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P=0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical prostatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P=0.04).Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk. A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment. (Funded by the Swedish Cancer Society and others.).
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Project description:Background:Infiltrating low-grade gliomas (LGG; WHO grade 2) typically present with seizures in young adults. LGGs grow continuously and usually transform to higher grade of malignancy, eventually causing progressive disability and premature death. The effect of up-front surgery has been controversial and the impact of molecular biology on the effect of surgery is unknown. We now present long-term results of upfront surgical resection compared with watchful waiting in light of recently established molecular markers. Materials and methods:Population-based parallel cohorts were followed from two Norwegian university hospitals with different surgical treatment strategies and defined geographical catchment regions. In region A watchful waiting was favored while early resection was favored in region B. Thus, the treatment strategy in individual patients depended on their residential address. The inclusion criteria were histopathological diagnosis of supratentorial LGG from 1998 through 2009 in patients 18?years or older. Follow-up ended 1 January 2016. Making regional comparisons, the primary end-point was overall survival. Results:A total of 153 patients (66 from region A, 87 from region B) were included. Early resection was carried out in 19 (29%) patients in region A compared with 75 (86%) patients in region B. Overall survival was 5.8?years (95% CI 4.5-7.2) in region A compared with 14.4?years (95% CI 10.4-18.5) in region B (P?<?0.01). The effect of surgical strategy remained after adjustment for molecular markers (P?=?0.001). Conclusion:In parallel population-based cohorts of LGGs, early surgical resection resulted in a clinical relevant survival benefit. The effect on survival persisted after adjustment for molecular markers.
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Project description:We examined patient reported outcomes among patients with prostate cancer treated with watchful waiting in a nationwide cohort.We collected treatment information and patient reported outcomes from 1,230 patients with prostate cancer diagnosed with T1-T2 prostate cancer in the Physicians' Health Study, of whom 125 were initially treated with watchful waiting. Cox proportional hazards regression was used to identify predictors of treatment initiation among patients on watchful waiting. Logistic regression was used to calculate the OR and 95% CI to assess disease targeted quality of life by initial treatment or watchful waiting.At a mean 7.3-year followup 41% of patients on watchful waiting remained free of treatment while 34% had received radiotherapy or brachytherapy, 16% had received primary hormonal therapy and 10% had undergone prostatectomy. Younger age, higher clinical stage, higher Gleason score and higher prostate specific antigen at diagnosis predicted progression to treatment. Watchful waiting compared to immediate treatment was associated with less urinary incontinence (3.5% vs 10%) and impotence (68% vs 78%) but more common obstructive urinary symptoms (22% vs 13%) on univariate analysis (each p <0.05). Incontinence and impotence differences remained significant after adjusting for age, comorbidity and time after cancer diagnosis. Quality of life outcomes in men who underwent delayed treatment after initially waiting were not worse than in men who underwent immediate treatment.Findings suggest quality of life benefits after watchful waiting in select patients with early stage prostate cancer compared to men treated immediately after diagnosis. Younger age and greater cancer severity at diagnosis predicted progression to treatment.
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Project description:Gender is increasingly recognized as an important factor in medicine, although it has long been neglected in medical research in many areas. We have studied the influence of gender in advanced rectal cancer with a special focus on radiosensitivity. For this purpose, we studied a cohort of 495 men (84.1% ≥ T3, 63.6% N1, 17.6%, M1) and 215 women (84.2% ≥ T3, 56.7% N1, 22.8%, M1) who all suffered from advanced rectal cancer and were treated with radiochemotherapy. The energy deposited, DNA double-strand break (dsb) repair, occurrence of chromosomal aberrations, duration of therapy, tumor regression and tumor-infiltrating lymphocytes, laboratory parameters, quality of life and survival were assessed. The residual DNA dsb damage 24 h after irradiation in lymphocytes was identical in both sexes. Furthermore, chromosomal aberrations accurately reflecting radiosensitivity, were similar in both sexes. There were no gender-dependent differences in tumor regression, tumor-infiltrating lymphocytes and outcome indicating no differences in the radiosensitivity of cancer cells. The irradiated tumor volume in women was slightly lower than in men, related to body weight, no difference was observed. However, when the total energy deposited was calculated and related to the body weight, women were exposed to higher amounts of ionizing radiation. During radiochemotherapy, decreases in blood lymphocyte counts and albumin and several quality-of-life parameters such as nausea and vomiting, loss of appetite, and diarrhea were significantly worse in women. There is no difference in radiation sensitivity between men and women in both normal tissue and tumors. During radiochemotherapy, the quality of life deteriorates more in women than in men. However, women also recover quickly and there are no long-term differences in quality of life.
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Project description: Not available
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Project description:To determine the short term efficacy and safety of tonsillectomy for recurrent streptococcal pharyngitis in adults. Design Randomised controlled trial.Academic referral centre in Finland.70 adults with documented recurrent episodes of streptococcal group A pharyngitis.Instant tonsillectomy (n=36) or remaining on waiting list as control (n=34).Percentage change in the risk of an episode of streptococcal pharyngitis at 90 days. Rates of all episodes of pharyngitis and days with symptoms and adverse effects.The mean (SD) follow-up was 164 (63) days in the control group and 170 (12) days in the tonsillectomy group. At 90 days, streptococcal pharyngitis had recurred in 24% (8/34) in the control group and 3% (1/36) in the tonsillectomy group (difference 21%; 95% confidence interval 6% to 36%). The number needed to undergo tonsillectomy to prevent one recurrence was 5 (3 to 16). During the whole follow-up, the rates of other episodes of pharyngitis and days with throat pain and fever were significantly lower in the tonsillectomy group than in the control group. The most common morbidity related to tonsillectomy was postoperative throat pain (mean length 13 days, SD 4).Adults with a history of documented recurrent episodes of streptococcal pharyngitis were less likely to have further streptococcal or other throat infections or days with throat pain if they had their tonsils removed.Clinical Trials NCT00136877.
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Project description:Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ?cT3b (up to 5?mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.
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