Background Cyclin‐dependent kinase 4/6 (CDK4/6) inhibitors, including palbociclib, are approved to treat hormone receptor (HR)‐positive/human epidermal growth factor receptor 2 (HER2)‐negative advanced breast cancer (ABC) and are associated with hematologic toxicity. African American women, who are underrepresented in CDK4/6 inhibitor clinical trials, may experience worse neutropenia because of benign ethnic neutropenia. The authors specifically investigated the hematologic safety of palbociclib in African American women with HR‐positive/HER2‐negative ABC. Methods PALINA was a single‐arm, open‐label, investigator‐initiated study of palbociclib (125 mg daily; 21 days on and 7 days off) plus endocrine therapy (ET) in African American women who had HR‐positive/HER2‐negative ABC and a baseline absolute neutrophil count ≥1000/mm3 (ClinicalTrials.gov identifier NCT02692755). The primary outcome was the proportion of patients who completed 12 months of therapy without experiencing febrile neutropenia or treatment discontinuation because of neutropenia. Single nucleotide polymorphism analysis was used to assess Duffy polymorphism status. Results Thirty‐five patients received ≥1 dose of palbociclib plus ET; 19 had a Duffy null polymorphism (cytosine/cytosine). There were no reports of febrile neutropenia or permanent study discontinuation because of neutropenia. Significantly more patients with the Duffy null versus the wild‐type variant had grade 3 and 4 neutropenia (72.2% vs 23.1%; P = .029) and required a palbociclib dose reduction (55.6% vs 7.7%; P = .008). Patients with the Duffy null versus the wild‐type variant had lower overall relative dose intensity (mean ± SD, 81.89% ± 15.87 and 95.67% ± 5.89, respectively; P = .0026) and a lower clinical benefit rate (66.7% and 84.6%, respectively). Conclusions These findings suggest that palbociclib is well tolerated in African American women with HR‐positive/HER2‐negative ABC. Duffy null status may affect the incidence of grade 3 neutropenia, dose intensity, and possibly clinical benefit.
Background/Aims: To explore the value of hysteroscope and laparoscope in removing an incarcerated or ectopic intrauterine device (IUD). Materials and Methods: A 33-year-old woman was admitted to the present hospital on May 22 nd , 2013. An incarcerated IUD was proven by ultrasonography. An IUD had been implanted in October 2011. Clinical case report of an incarcerated IUD in the sigmoid colon. Results: An IUD was successfully removed with the assistance of hysteroscope and laparoscope. Conclusion: Ultrasonography should be performed in the follow-up of the patients after IUD implantation. Ectopic or incarcerated IUD can be successfully removed with the assistance of hysteroscope and laparoscope with minimal trauma.
Intraoperative radiotherapy (IORT) is a novel and increasingly utilized radiation technique in the treatment of breast carcinoma. There are few reports on the histologic changes seen in breast tissue from patients who have undergone IORT. We sought to evaluate the histologic changes observed in specimens received following IORT, as well as report an unusual case which prompted our study. A retrospective review of patients who received IORT and subsequently had breast tissue histologically evaluated at our institution was performed. Fifteen post-IORT specimens from 12 patients, including the patient from the reported case, were studied. We report a case of a 77-year-old woman found to have mammographic microcalcifications at the lumpectomy site 6 months following lumpectomy and IORT for ductal carcinoma in situ (DCIS). A stereotactic biopsy showed abundant desquamated anucleate squamous cells with calcification and keratin material associated with squamous metaplasia of ducts. Carcinoma was not present. The predominant findings in the post-IORT specimens were fat necrosis and scar (n = 5), recurrent invasive carcinoma (n = 5), surgical site changes (n = 3), abscess (n = 1), and exuberant squamous metaplasia with calcification (n = 1). Five of fifteen (33%) post-IORT specimens showed squamous metaplasia, all of which were collected within 6 months of IORT delivery. The morphologic changes observed after IORT are similar to those seen after external beam radiotherapy. Exuberant squamous metaplasia is an uncommon consequence of IORT; however, pathologists should be aware of this phenomenon and review a history of prior intraoperative radiation before raising concern for malignancy.
For early stage breast cancer patients who have received whole breast radiotherapy as part of their initial treatment, and then present with ipsilateral breast recurrence, a standard treatment option is mastectomy. Recent reports indicate that well-selected patients can be treated with a second breast conserving surgery and partial breast reirradiation with good toxicity and clinical outcomes. We report the patient characteristics and clinical outcomes for patients treated with a second breast conserving treatment with intraoperative radiotherapy (IORT) at our institution. Materials/Methods: Records were retrospectively reviewed of 61 locally recurrent breast cancer patients treated with IORT in the setting of a second breast conserving treatment from 2012-2017. All patients had refused mastectomy and elected for a second breast conserving treatment. Results: The median age at time of IORT was 71 years old (range: 44 e 85). The median time interval between the initial surgery and the second surgery was 15.8 years (2.3 e 30.3). The median tumor size was 0.7 cm (0.05 e 2.7). The histologies of the recurrent tumors were 55.7% invasive ductal carcinoma, 18.0% invasive lobular carcinoma, and 24.6% ductal carcinoma in situ. Regarding receptor status, 55/61 (90.2%) were ER or PR positive, 8/61 (13.1%) were Her2+, and 2/61 (3.3%) were triple-negative. Regarding histologic grade, 4/57 (7.0%) were low-grade, 29/57 (50.9%) were intermediate-grade, and 24/57 (42.1%) were high-grade. There was node positivity in 5/61 (8.2%) patients. At a median follow-up time of 10.3 months (0.0 e 51.7), there were 2 distant recurrences (2/61 Z 3.3%) and 3 local recurrences (3/61 Z 4.9%). The two patients with distant recurrence were both diagnosed with bone metastases within a few months of the second breast conserving treatment; both were node-positive. The three local recurrences occurred at 24, 16, and 21 months after the second breast conserving treatment. Two underwent subsequent bilateral mastectomies and the third underwent a third lumpectomy; all three are currently without evidence of disease. Conclusion: For carefully selected patients with locally recurrent breast cancer, IORTas part of a second breast conserving treatment appeared to show acceptable short term clinical outcomes. Nodal status may be a risk factor for a second recurrence. Longer follow-up and proper risk stratification will be necessary to demonstrate efficacy as an alternative treatment option.
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