مقاله شماره ۲۸
#Oncology
#Gynecology
عنوان:
Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer
مجله:
The New England Journal of Medicine
تاریخ انتشار:
Nov, 2019
سایتیشن:
Coleman et al.
چکیده:
BACKGROUND
Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation.
METHODS
We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival.
RESULTS
A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery.
CONCLUSIONS
In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone.
DOI: https://www.nejm.org/doi/10.1056/NEJMoa1902626
توضیحات:
The authors of this multinational, randomized, phase III clinical trial compared outcomes of secondary surgical cytoreduction followed by platinum-based chemotherapy versus platinum-based chemotherapy alone in 485 women with resectable, platinum-sensitive, recurrent ovarian cancer. The median overall survival was 50.6 months following surgery compared with 64.7 months without surgery. The hazard ratio for death was 1.29 with surgery compared with platinum-based chemotherapy alone (P=.08). Surgery was not associated with improved outcomes even when comparing only 67% of surgical patients who achieved complete gross resection with the chemotherapy-alone cohort.
🔎 @Meditorha
#Oncology
#Gynecology
عنوان:
Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer
مجله:
The New England Journal of Medicine
تاریخ انتشار:
Nov, 2019
سایتیشن:
Coleman et al.
چکیده:
BACKGROUND
Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation.
METHODS
We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival.
RESULTS
A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery.
CONCLUSIONS
In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone.
DOI: https://www.nejm.org/doi/10.1056/NEJMoa1902626
توضیحات:
The authors of this multinational, randomized, phase III clinical trial compared outcomes of secondary surgical cytoreduction followed by platinum-based chemotherapy versus platinum-based chemotherapy alone in 485 women with resectable, platinum-sensitive, recurrent ovarian cancer. The median overall survival was 50.6 months following surgery compared with 64.7 months without surgery. The hazard ratio for death was 1.29 with surgery compared with platinum-based chemotherapy alone (P=.08). Surgery was not associated with improved outcomes even when comparing only 67% of surgical patients who achieved complete gross resection with the chemotherapy-alone cohort.
🔎 @Meditorha
New England Journal of Medicine
Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer | NEJM
Original Article from The New England Journal of Medicine — Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer
مقاله شماره ۳۰
#Gynecology
#Oncology
عنوان:
Supplemental MRI Screening for Women With Extremely Dense Breast Tissue
مجله:
The New England Journal of Medicine
نوع مطالعه:
RCT
تاریخ انتشار:
Nov, 2019
سایتیشن:
Bakker et al.
چکیده:
BACKGROUND
Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.
METHODS
In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.
RESULTS
The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.
CONCLUSIONS
The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period.
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa1903986
توضیحات مهم:
✅ در این مطالعه، ۴۰۳۷۳ زن در محدودع سنی ۵۰ تا ۷۵ سال با بافت پستان extremely dense و نتایج غربالگری نرمال ماموگرافی بصورت رندوم به دو گروه supplemental MRI و فقط ماموگرافی تقسیم شدند.
✔️ The interval cancer rate was significantly lower in the MRI-invitation group compared with the mammography-only group.
✔️ Among the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in women who underwent MRI and 16 were diagnosed in those who did not accept the invitation.
✔️Among the women who underwent MRI screening, the cancer-detection rate was 16.5 per 1000 screenings.
✔️ The positive predictive value was 17.4% for recall for additional testing and 26.3% for biopsy, whereas the false-positive rate was 79.8 per 1000 screenings.
✔️✔️ نتایج این مطالعه نشان می دهد که supplemental MRI در زنان با بافت پستان extremely dense و ماموگرافی نرمال منجر به تشخیص کمتر قابل توجهی از کنسرهای interval در مقایسه با ماموگرافی به تنهایی می شود.
🔎 @Meditorha
#Gynecology
#Oncology
عنوان:
Supplemental MRI Screening for Women With Extremely Dense Breast Tissue
مجله:
The New England Journal of Medicine
نوع مطالعه:
RCT
تاریخ انتشار:
Nov, 2019
سایتیشن:
Bakker et al.
چکیده:
BACKGROUND
Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.
METHODS
In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.
RESULTS
The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.
CONCLUSIONS
The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period.
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa1903986
توضیحات مهم:
✅ در این مطالعه، ۴۰۳۷۳ زن در محدودع سنی ۵۰ تا ۷۵ سال با بافت پستان extremely dense و نتایج غربالگری نرمال ماموگرافی بصورت رندوم به دو گروه supplemental MRI و فقط ماموگرافی تقسیم شدند.
✔️ The interval cancer rate was significantly lower in the MRI-invitation group compared with the mammography-only group.
✔️ Among the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in women who underwent MRI and 16 were diagnosed in those who did not accept the invitation.
✔️Among the women who underwent MRI screening, the cancer-detection rate was 16.5 per 1000 screenings.
✔️ The positive predictive value was 17.4% for recall for additional testing and 26.3% for biopsy, whereas the false-positive rate was 79.8 per 1000 screenings.
✔️✔️ نتایج این مطالعه نشان می دهد که supplemental MRI در زنان با بافت پستان extremely dense و ماموگرافی نرمال منجر به تشخیص کمتر قابل توجهی از کنسرهای interval در مقایسه با ماموگرافی به تنهایی می شود.
🔎 @Meditorha
New England Journal of Medicine
Supplemental MRI Screening for Women with Extremely Dense Breast Tissue | NEJM
Original Article from The New England Journal of Medicine — Supplemental MRI Screening for Women with Extremely Dense Breast Tissue