They explain that the GIM2 study previously demonstrated that women with node-positive early breast cancer did not derive a significant survival benefit from the use of fluorouracil alongside epirubicin, cyclophosphamide, and paclitaxel, but that giving the regimen every 2 weeks instead of every 3 weeks improved both disease-free survival (DFS) and overall survival (OS).

All patients were then given four cycles of epirubicin 90 mg/m 2 plus cyclophosphamide 600 mg/m 2 every 2 or 3 weeks, according to the physician’s choice.

The latter consisted of four cycles of docetaxel 75 mg/m 2 followed by four cycles of epirubicin 75 mg/m 2 plus cyclophosphamide 500 mg/m 2 .

After a median 15 years of follow-up, the OS rate was 77.6% for the 751 patients with axillary node-positive or high-risk node-negative disease who were randomly assigned to receive three cycles of docetaxel plus capecitabine followed by three cycles of cyclophosphamide, epirubicin, and capecitabine.

In all, 1174 patients with previously untreated, nonmetastatic (stage T1c N1-2 or T2-4 N0-2), triple-negative disease were randomly allocated to treatment with neoadjuvant pembrolizumab 200 mg (n=784) or placebo (n=390) every 3 weeks, each given with four cycles of paclitaxel plus carboplatin, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide.

Initially, the patients were randomly assigned to receive adjuvant chemotherapy with three cycles of fluorouracil, epirubicin, and cyclophosphamide followed by three cycles of docetaxel with or without gemcitabine.

After this, both groups received additional nab-paclitaxel 125 mg/m² weekly for 12 weeks then epirubicin 90 mg/m 2 and cyclophosphamide 600 mg/m 2 every 2 weeks for 4 cycles.

The 397 patients with stage IIA–III disease recruited to the open-label, phase 2 cardiac safety study were assigned by physician’s choice to receive one of the neoadjuvant treatment regimens outlined below: four cycles of dose-dense doxorubicin plus cyclophosphamide (AC) followed by 12 cycles of weekly paclitaxel alongside four cycles of concurrent pertuzumab–trastuzumab every 3 weeks; four cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) every 3 weeks followed by four cycles of docetaxel alongside four cycles of concurrent pertuzumab–trastuzumab every 3 weeks.

This was significantly higher than the 80.3% rate for their 322 counterparts who instead received three cycles of cyclophosphamide 500 mg/m 2 , epirubicin 100 mg/m 2 , and fluorouracil 500 mg/m 2 every 3 weeks followed by three cycles of 3-weekly docetaxel 100 mg/m 2 , and equated to a hazard ratio (HR) of 0.65 favoring the platinum-based regimen.

The CBCSG010 researchers therefore believe that capecitabine used concomitantly with docetaxel and epirubicin plus cyclophosphamide could be “an alternative adjuvant regimen” for this patient population.

This was not significantly different from the rate of 67% observed among the 219 patients assigned to receive three cycles of the anthracycline-containing regimen of 5-fluoruoracil 500 mg/m 2 , epirubicin 90 mg/m 2 , and cyclophosphamide 500 mg/m 2 followed by six cycles of paclitaxel and carboplatin.

Following preoperative chemotherapy, which consisted of three cycles of epirubicin, cisplatin, and capecitabine, or epirubicin, oxaliplatin, and capecitabine, 95% of patients in the chemotherapy group and 93% of those in the chemoradiotherapy group proceeded to surgery, with a potentially curative resection done in 79% and 83%, respectively.

In the phase III tAnGo trial, women with newly diagnosed, early-stage breast cancer of any nodal and hormonal status were randomly assigned to receive either four cycles of intravenous epirubicin 90 mg/m 2 and cyclophosphamide 600 mg/m 2 followed by four cycles of paclitaxel 175 mg/m 2 infused over 3 hours or to the same chemotherapy regimen plus intravenous gemcitabine 1250 mg/m 2 during the paclitaxel cycles.

Compared with the 360 patients given epirubicin, cisplatin, and infused 5-fluorouracil (ECF), prespecified sensitivity analysis indicated that the 356 patients randomly assigned to receive FLOT achieved significantly greater overall survival (OS), with a hazard ratio (HR) of 0.76.

And indeed, in a group of 118 patients with nonmetastatic lymph node-positive disease who received adjuvant treatment with a combination of 5-fluorouracil, anthracycline (doxorubicin or epirubicin) and cyclophosphamide, distant metastasis-free survival was significantly longer for those with low than high mtDNA content (dichotomized by the median of 758 molecules/cell), at a median of 85 and 34 months, respectively.

In this roundup we report on three phase III trials, two investigating trastuzumab emtansine in HER2-positive breast cancer and one assessing tailored neoadjuvant therapy in soft tissue sarcoma, and also on an analysis of postmarketing safety events.

In the current study, Francisco Esteva (New York University Langone Medical Center, USA) and colleagues randomly assigned 549 women with stage I–IIIa operable HER2-positive breast cancer to receive eight 3-week cycles of neoadjuvant CT-P6 or reference trastuzumab intravenously (8 mg/kg on day 1 of cycle 1 and 6 mg/kg on day 1 of cycles 2–8) in conjunction with neoadjuvant docetaxel (75 mg/m 2 on day 1 of cycles 1–4) and FEC (fluorouracil 500 mg/m 2 , epirubicin 75 mg/m 2 , and cyclophosphamide 500 mg/m 2 ; day 1 of cycles 5–8) therapy.

Just under half (48.1%) of the 530 participants with operable gastric, Siewert type I–III esophagogastric junction, or lower esophageal adenocarcinoma who received bevacizumab alongside three cycles of chemotherapy with epirubicin, cisplatin, and capecitabine before and after surgery were alive at 3 years.