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Adding bevacizumab (Avastin) to chemotherapy improved overall survival (OS) for women with cervical cancer, according to final results from the phase III Gynecologic Oncology Group (GOG) 240 trial published online in the Lancet.
There were 348 deaths by March 7, 2014, meeting the prespecified cutoff for final analysis.
At that point, investigators determined that patients assigned to chemotherapy plus bevacizumab continued to show significant improvement in OS, compared with chemotherapy- alone groups, at a median OS of 16.8 versus 13.3 months (HR, 0.77; 95% CI, 0.62- 0.95; P = .007).
I n a head-to-head study, NEPA (Akynzeo)—a novel combination of a neurokinin-1 (NK1) receptor antagonist and the 5-HT3 receptor antagonist palonosetron (Aloxi)—had noninferior efficacy, compared with a conventional aprepitant regimen, for preventing chemotherapy-induced nausea and vomiting (CINV).1 This trial focused on Asian patients receiving cisplatin-based highly emetogenic chemotherapy (HEC) as first-line treatment and showed promising activity in this patient population.
NEPA can provide an almost immediate positive effect on patients receiving HEC and, because it is a single-dose oral drug, facilitate patients taking anti- CINV medication as prescribed. “The availability of an oral antiemetic targeting 2 antiemetic pathways in a convenient single capsule can make chemotherapy less burdensome for patients with cancer, especially those undergoing HEC regimens,” said the trial’s primary investigator, Li Zhang, MD, of the Sun Yat-sen University Cancer Center, in Guangzhou, China. Zhang presented the data at the 2017 Multinational Association of Supportive Care in Cancer Annual Meeting in Washington, DC.
The double-blind, phase III study randomized 828 chemotherapy-naïve Asian patients receiving cisplatin-based HEC to receive either a single oral dose of NEPA (300 mg of netupitant and 0.5 mg of palonosetron) or a 3-day oral aprepitant/granisetron regimen (125 mg of oral aprepitant combined with 3 mg of intravenous granisetron). Both arms also received oral dexamethasone. Patients who had an ECOG performance status of 0, 1, or 2 and were scheduled to receive their first course of cisplatin-based chemotherapy were eligible for the study.
In the NEPA arm (n = 413), 70.7% of patients were male, the mean age was 54.6 years, and the median dose of cisplatin received was 73 mg/ m2. In the aprepitant/granisetron arm (n = 416), 71.4% of patients were male, the median age was 54.5 years, and the median dose of cisplatin received was 72 mg/m2. ECOG performance statuses were balanced between the NEPA and aprepitant/ granisetron arms (Table). In both arms, the most common cancer type was lung cancer.1
The primary endpoint was complete response (CR), defined as patients having no emesis and no need for rescue medication for CINV. Secondary endpoints for analysis included patients having no emesis or significant nausea and the daily rates of CINV events.
The CR rates were assessed in 3 time frames: acute (CINV events occurring in 0-24 hours), delayed (25-120 hours), and overall (0-120 hours). Rates were similar between the 2 arms, with CR rates in the acute period at 84.5% in the NEPA arm and 87% in the aprepitant/granisetron arm; 77.9% and 74.3% in the delayed period, respectively; and 73.8% and 72.4% overall, respectively.1
Notably, although the overall CR rates were similar for the 2 arms, the daily rates of patients experiencing CINV remained between 13% and 15% for the aprepitant/granisetron arm over 5 days, yet declined from 16% to 8% for NEPA.1
This study was powered to demonstrate only NEPA’s noninferiority, not superiority, to aprepitant/ granisetron; however, there is clear potential for NEPA rising above the conventional regimen. “The selectivity and convenient dosing of NEPA should make it an attractive option for many patients undergoing HEC,” Zhang commented.
Incidence of treatment-related adverse events (TRAEs) was similar in the 2 arms (18.4% for NEPA vs 14.4% for aprepitant/granisetron), as was the incidence of serious TRAEs (0.5% in both arms), according to Zhang. The most common TRAEs were constipation (8.0% in the NEPA arm vs 6.3% in the aprepitant/granisetron arm) and hiccups (2.7% vs 1.4%, respectively). Part of what makes NEPA such a promising regimen is its mechanism of action as a combination therapy. “For patients receiving HEC, optimal control of CINV requires co-administration of antiemetics that inhibit multiple molecular pathways.
One of the more commonly recommended regimens for preventing and treating CINV is one that combines a selective 5-HT3 receptor antagonist, an NK1 receptor antagonist, and a corticosteroid,” Zhang explained.
Chemotherapy causes nausea and vomiting by stimulating the release of serotonin from the enterochromaffin cells of the small intestine. Serotonin then activates 5-HT3 receptors located on the terminals of the vagus nerve, which reflexively causes vomiting. The development of acute emesis depends on serotonin, and its 5-HT3 receptors have been shown to selectively stimulate the emetic response.2
Netupitant is a selective antagonist of NK1 receptors. The other component of NEPA, palonosetron, is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Palonosetron prevents nausea and vomiting during the acute phase of CINV, and netupitant prevents nausea and vomiting during both the acute and delayed phases after chemotherapy.2
Oral NEPA has been approved in the United States and Europe after demonstrating superior efficacy in preventing CINV compared with palonosetron alone, in patients taking cisplatin chemotherapy.
The earlier trial was a multicenter, randomized, double-blind, parallel-group study comparing oral NEPA (n = 135) with oral palonosetron (n = 136) in patients receiving high-dose cisplatin chemotherapy. Of patients treated with NEPA, 90% achieved a CR versus 77% in palonosetron group.3
Almost all patients treated with NEPA experienced a CR during the acute phase of CINV, compared with 90% of patients receiving palonosetron (P = .002). Additionally, 90% of patients in the NEPA group achieved a CR during the delayed phase of CINV versus 80% in the oral palonosetron group (P = .032).3
Despite these positive results, a study comparing NEPA with other treatments had never been done. “Prior to our study, none of the NK1 receptor antagonist—containing regimens had been compared with each other in a head-to-head phase III trial. That is why we chose to compare oral NEPA with aprepitant/granisetron,” Zhang said.
In terms of future research, Zhang noted that the team plans to conduct prespecific analyses of this study, such as for different tumor types and different ethnic groups.
1. Zhang L, Lu S, Feng J, et al. Phase 3 study of NEPA versus 3-day oral aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in highly emetogenic chemotherapy (HEC) setting. Abstract presented at: 2017 Multinational Association of Supportive Care in Cancer Annual Meeting; June 22-24, 2017; Washington, DC. Abstract PS049.
2. Akynzeo [prescribing information]. Lugano, Switzerland: Helsinn Group; December 2016. www.akynzeo.com/assets/ pdf/prescribing_information.pdf. Accessed July 26, 2017.
3. Hesketh PJ, Rossi G, Rizzi G, et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol. 2014;25(7):1340-1346. doi: 10.1093/ annonc/mdu110.
Hospice enrollment is low and use of aggressive treatment is high for elderly patients with acute myeloid leukemia (AML), a situation investigators called “suboptimal” in results from a retrospective study recently published in the Journal of Clinical Oncology.1
Among the 5847 patients in the study who enrolled in hospice, 47.4% did so within the final 7 days of life; 28.8%, within 3 days of dying. The investigative team, led by Rong Wang, PhD, a research scientist with Yale University’s COPPER Center, found that the percentage of patients entering hospice steadily increased from 1999 to 2012, but that was largely due to patients enrolling within 7 days of death.
End-of-life care is of particular concern for elderly patients with AML because prognosis is poor and has not changed in several decades. Median survival for patients aged 65 or older is roughly 2 months and drops to as low as 1 month for patients ≥85 years.
Investigators conducted a population-based, retrospective cohort study based on data from 13,156 patients aged ≥65 years who were diagnosed with AML from 1999 to 2011 and died before December 31, 2012. Medicare claims were used to assess patterns of hospice care and use of aggressive treatment.
“Our findings suggest that hospice is not being used optimally to provide end-of-life care for older patients with AML,” wrote Wang et al. “Unrealistic expectations of patients, families, and physicians have been cited as factors contributing to the underuse of hospice in patients with AML, but the current hospice model itself may not be well suited to handle the rapid clinical decline and medical complications commonly experienced by older patients with AML approaching the end of life. The increased overall use of hospice with concomitant increase in the proportion admitted within 7 days of death raises the question of whether patients are simply being admitted to hospice to manage death rather than obtaining the benefits of symptom management and palliative support that hospice can provide.”
The researchers suggested that cytopenia might be an obstacle to getting these patients enrolled in hospice earlier. Transfusion is an important part of supportive care for patients with AML, but a national survey of 591 hospices showed that 40% did not admit patients with transfusion needs, and Wang et al noted that some patients left hospice, then received treatment, usually transfusion support rather than chemotherapy.
“Although many hematologic oncologists acknowledged the importance of hospice care, the lack of availability of transfusions in the hospice setting is an important concern for hospice referral.
Taken together, the transfusion needs of patients with AML may constitute a barrier to timely hospice enrollment and prompt hospice disenrollment,” the investigators wrote.
Men and nonwhite patients were less likely to enroll in hospice, which is consistent with recognized sex and racial disparities in end-of-life care.
The investigators said that physician and patient education and expanded use of culturally sensitive end-of-life care may help address those disparities. Patients with longer survival (≥30 days) were more likely to enroll in hospice (48.1% vs 30.7%; P = .01). Among those enrolled in hospice, nearly half (51.2%) of patients who died within 30 days of starting their first stay in hospice enrolled in the last 3 days of life, compared with only 24.9% of patients who survived longer.
Wang et al found that use of chemotherapy in the final 14 days of life became more common over time, increasing from 7.7% in 1999 to 18.8% by 2012 (P <.01 for trend). Patients who received chemotherapy within the last 14 days of life were more likely to be in an intensive care unit during the last 30 days of life (43.0% vs 28.4%; P <.01) but less likely to enroll in hospice (22.1% vs 47.4%; P <.01) compared with patients who did not undergo such aggressive treatment.
Multivariate analysis showed that men, married people, and patients who died more recently were more likely to receive chemotherapy in the final 2 weeks of life. Older patients, those who had state Medicaid buy-in, those who lived outside the Northeast, and those who lived outside of major metropolitan areas were less likely to receive late chemotherapy.
Wang R, Zeidan AM, Halene S, et al. Health care use by older adults with acute myeloid leukemia at the end of life [published online August 7, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.72.7149.
Carol Bush, BS, RN Oncology Nurse Consultant The Social Nurse, LLC Wichita, Kansas
The word palliate means “to alleviate or to moderate intensity.” In the context of cancer care, palliative care means “to focus medical care or treatment on preventing or relieving suffering associated with serious illness.”
In the United States, palliative care can be a part of medical care at various times during the course of an illness. Whether it is during the time of treatment or when there are no options for further treatment, relief or palliation of symptoms can be very important to preserving one’s quality of life.
Sometimes, palliative care and hospice care are used interchangeably, and this may result in confusion. Hospice care most often means a change in focus from treatment of a life-threatening disease to a focus on relief of symptoms with an understanding that all possible treatments to cure the disease have been exhausted. Palliative care is a major focus of hospice care. Palliative care initially evolved from hospice care. However, it has expanded to include the relief of symptoms associated with curative treatment as well.
Through an initiative called the National Consensus Project, 5 major US palliative care organizations have collaborated to publish guidelines that provide a comprehensive description of what constitutes quality palliative care. Initiatives of this nature have developed because an increased number of people are living with chronic, debilitating, and/or life-threatening illnesses.
Palliative care is a purposefully interdisciplinary approach to care that challenges this narrow focus on the body and the limits of looking at care as being provided only in the context of doing something to the patient. Palliative care teams often consist of nurses, physicians, social workers, and chaplains who seek to use individual and collective expertise to look at the mind, body, and spiritual needs of patients and their families as they face life-limiting and life-threatening conditions. Palliative care teams focus on understanding a person’s values and goals, how they define quality of life, and how they want to spend their time, energy, and resources. They support hope and care throughout one’s life and course of an illness and believe that the relief of suffering at all levels—mind, body, and spirit—is care that we can always provide.
Palliative care is appropriate at all stages of one’s illness, from initial diagnosis to living with a chronic illness to the end of life.
A palliative care team is often reminded that although we can sometimes help by doing things to a patient, eg, tests, procedures, etc, there are times when these interventions are no longer effective. We can always focus on the things we do for a patient. That something is called care!
Phase III results from the PROSELICA trial showed that 20 mg/m2 of cabazitaxel (Jevtana) was as safe and effective as the 25-mg/m2 dose for postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC). The findings were published online in the Journal of Clinical Oncology.
Median overall survival (OS) for patients assigned to the 20-mg/m2 dose (C20) was 13.4 months versus 14.5 months for those assigned to the 25-mg/m2 dose (C25; HR, 1.024). The 1-sided 98.89% upper boundary of the confidence interval (UCI) of the hazard ratio was 1.184, which was less than the 1.214 noninferiority margin, thus satisfying the predefined criteria for noninferiority in the intent-to-treat population of patients.
Noninferiority was defined as maintenance of ≥50% of the OS benefit associated with C25 versus mitoxantrone in the TROPIC trial, with 95% CI. The UCI of the HR for C20 versus C25 could not exceed 1.214 under a 1-sided 98.89% CI after interim analyses. Secondary endpoints included progression-free survival (PFS), prostate specific antigen (Prostate Specific Antigen), tumor and pain responses and progression, health-related quality of life, and safety.
“PROSELICA provides further evidence of the efficacy of cabazitaxel in the treatment of patients with mCRPC who have previously received docetaxel,” first author Mario Eisenberger, MD, of Johns Hopkins University, and coinvestigtors wrote. “Data also suggest that patients can achieve a similar clinical benefit from cabazitaxel at both the 20 mg/m2 and 25 mg/m2 starting doses and that dose reductions may be implemented in patients who require them without significant detriment to outcome.”
To determine whether the 20-mg/m2 dose was noninferior for OS, researchers assigned 598 patients with mCRPC to the C20 group and 602 to the C25 group in a phase III, randomized, open-label trial. Patients enrolled at 172 centers in 22 countries worldwide from April 2011 to December 2013.
More than 85% of patients in both groups had increasing PSA levels at baseline, and most patients in each group had received at least 1 cycle of docetaxel. Nearly half of all patients in each arm had received 3 or more regimens of hormonal therapy. Of the total randomly assigned population, 308 patients (25.7%) had received prior targeted therapy with abiraterone acetate (Zytiga) or enzalutamide (Xtandi). Median time between last dose of docetaxel and random assignment and median time between last dose of docetaxel and disease progression were similar between the 2 groups.
In a secondary analysis of the per-protocol population evaluating only patients who had received at least 3 doses of cabazitaxel, the observed median OS for patients receiving C20 was 15.1 months, compared with 15.9 months for C25 (HR, 1.042).
The 1-sided 98.89% UCI of the HR was 1.224, which exceeded the 1.214 noninferiority margin and thus did not confirm the noninferiority of the C20 dose, compared with the C25 dose for OS. Median PFS was 2.9 months in the C20 arm verse 3.5 months in patients receiving C25 (HR, 1.099; 95% CI, 0.974-1.240). Researchers observed similar rates in each arm for tumor, PSA, and pain progression. The most frequent PFS events were PSA progression (C20, 39.8%; C25, 34.7%) and pain progression (C20, 25.8%; C25, 28.1%).
There was no significant difference in the tumor response rate in evaluable patients receiving C20 and C25 (18.5% vs 23.4%, respectively; nominal P = .1924). Median time to tumor progression was 9 months for patients receiving C20 and 9.3 months for patients receiving C25 (HR, 1.096; 95% CI, 0.902-1.331).
PSA response rates were significantly higher in the C25 arm, with 29.5% of C20 patients and 42.9% of C25 patients demonstrating a ≥50% decline in PSA from baseline (nominal P <.001). Median time to PSA progression was 6.8 months or longer for patients receiving C25, compared with 5.7 months in the C20 arm (HR, 1.195; 95% CI, 1.025-1.393).
Researchers observed no significant difference in the number of patients who experienced a pain response, and the rate of pain progression was similar in the 2 groups. Median time to pain progression was 6.2 months for patients receiving C20 versus 6.4 months for patients assigned to C25, with a similar risk of pain progression in both groups (HR, 1.046; 95% CI, 0.874-1.251).
The safety population consisted of 580 patients assigned to C20 and 595 assigned to C25 who received at least 1 dose of cabazitaxel. Patients in the C20 group received a median of 6 treatment cycles for a median duration of 18 weeks. Patients in the C25 group received a median of 7 treatment cycles for a median duration of 21 weeks.
“The safety profiles of both doses were consistent with previous reports, with a relatively low incidence of manageable grade ≥3 adverse effects, particularly with the lower cabazitaxel dose,” Eisenberger et al wrote.
Cabazitaxel at 25 mg/m2 has been FDA approved in combination with prednisone in this patient population since 2010, but early phase studies showed that the 20-mg/m2 dose was associated with less grade 3/4 neutropenia (57.1% vs 82.1%).
More patients receiving C25 had dose delays and reductions, compared with patients receiving C20. The most common treatment-emergent adverse effect (AE) leading to death was neutropenic sepsis (C20, 0.2%; C25, 0.5%). The most frequent nonhematologic treatment-emergent AEs possibly related to study treatment in both cabazitaxel groups were diarrhea, nausea, and fatigue. More patients in the C25 arm experienced serious treatment-emergent AEs (30.5% vs 43.2%).
Overall, 95 patients (16.4%) assigned to C20 discontinued treatment due to toxicity, along with 19.5% of the C25 cohort.
In the C20 group, 41.8% experienced grade ≥3 neutropenia, compared with 73.3% of patients in the C25 group. Researchers observed grade ≥3 febrile neutropenia in 2.1% of the C20 group and 9.2% of the C25 group. In the C20 arm, 11 patients (1.9%) reported grade ≥3 hematuria versus 25 patients (4.2%) in the C25 arm. Incidence of grade ≥3 alopecia, fatigue, and neuropathy was low in both arms.
Researchers determined that 2.1% of deaths within 30 days of the last dose of cabazitaxel in the C20 group and 3.2% of such deaths in the C25 group were the result of AEs. 
Eisenberger M, Hardy-Bessard A, Kim CS, et al. Phase III study comparing a reduced dose of cabazitaxel (20 mg/ m2) and the currently approved dose (25 mg/m2) in postdocetaxel patients with metastatic castration-resistant prostate cancer—PROSELICA [published online August 15, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.74.7931.
Neoadjuvant T-DM1 (ado-trastuzumab emtansine; Kadcyla) may offer a safe, effective option for some patients with breast cancer, according to findings recently published online in the Journal of Clinical Oncology. The researchers reported that 12 weeks of T-DM1—with or without endocrine therapy—induced superior pathologic complete response (pCR), compared with trastuzumab (Herceptin) plus endocrine therapy in patients with HER2-positive (HER2+) and HR-positive (HR+) early breast cancer. In the prospective, neoadjuvant phase II ADAPT trial conducted by the West German Study Group, pCR was 41% for patients assigned to T-DM1 alone and 41.5% for those who received T-DM1 and endocrine therapy. In contrast, 15.1% of patients assigned to trastuzumab and endocrine therapy had a pCR (P <.001).
Early response was defined as a ≥30% decrease in the Ki-67 level after a single therapy cycle. Two-thirds of patients who responded were early responders. Of those, 35.7% achieved a pCR, compared with 19.8% in nonresponders (odds ratio, 2.2; 95% CI, 1.24-4.19; P = .005).“Only 4 cycles of neoadjuvant T-DM1 in HER2-positive/HR-positive early breast cancer yield substantial pCR rates— quite comparable to standard chemotherapy plus trastuzumab (or even to dual HER2 blockade).
T-DM1 may be an efficient and safe alternative for patients who are not suited for systemic chemotherapy in this setting; the addition of endocrine therapy does not seem to play a crucial role,” first author Nadia Harbeck, MD, of the University of Munich, and coinvestigators wrote. “Our trial results add to the existing evidence that HER2-positive early breast cancer may require approaches that differ regarding the treatment of the luminal (HR-positive) and the nonluminal (HR-negative) subtypes.”
Investigators enrolled 375 patients with early HER2+ and HR+ breast cancer at 48 centers from October 2012 to March 2015. The intent-totreat population included 119 patients randomly assigned to T-DM1 (3.6 mg/kg body weight every 3 weeks for 4 cycles; arm A); 127, T-DM1 (same regimen) plus endocrine therapy (arm B); and 129, trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg every 3 weeks for 3 more cycles) plus endocrine therapy (arm C).
The median ages in the arms ranged from 50 to 51.5 years, and investigators said the characteristics were well balanced between the 3 groups. In arms A, B, and C, respectively, rates of cT1 tumors were 50.4%, 48.8%, and 46.5%, and cN0 tumor rates were 71.4%, 75.6%, and 70.5%. Progesterone receptor—negative tumors in the arms were 17.6%, 15.7%, and 16.3%, prospectively. For arms A, B, and C, respectively, rates of near pCR (ypT1a or ypT0/is) were 52.9%, 52.9%, and 19.3%; rates of total pCR (ypT0, ypN0) were 32.5%, 34.1%, and 10.1%; and rates of ypT0/is were 42.4%, 43.4%, and 19.2%.
Postmenopausal women assigned to T-DM1 alone had a pCR rate of 44.1% versus 37.9% for premenopausal women. The rates were 45% versus 38.1% and 16.7% versus 13.6% for the T-DM1 plus endocrine therapy and the trastuzumab plus endocrine therapy groups, respectively.
Although these pCR rates were numerically higher in postmenopausal women, the difference was not statistically significant overall (P = .3) or within treatment arms (arm A, P = .57; arm B, P = .47; arm C, P = .8). None of the premenopausal patients received a gonadotropin-releasing hormone analog and an aromatase inhibitor.
T-DM1 was associated with a significantly higher prevalence of grade 1 to 2 toxicities, especially thrombocytopenia, nausea, and elevation of liver enzymes. Investigators observed 17 therapyrelated serious adverse effects (AEs) (arm A, 5.3%; arm B, 3.1%), including 4 serious grade ≥3 AEs (2 each in arms A and B) and 1 each for alanine aminotransferase increase, corneal cyst, hypertensive crisis, and hypersensitivity reaction. All patients recovered without sequelae.
In the T-DM1—containing arms, 7.5% of patients experienced at least 1 grade ≥3 AE, compared with 4.1% in arm C (P = .26). Increases in transaminases were the most common AE (112 observed in 103 patients).
“In summary, no new safety signals for T-DM1 were detected, and overall toxicity was favorable in all 3 treatment arms,” Harbeck et al wrote. 
Harbeck N, Gluz O, Christgen M, et al. De-escalation strategies in human epidermal growth factor receptor 2 (HER2)—positive early breast cancer (BC): final analysis of the West German Study Group adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early BC HER2- and hormone receptor–positive phase II randomized trial—efficacy, safety, and predictive markers for 12 weeks of neoadjuvant trastuzumab emtansine with or without endocrine therapy (ET) versus trastuzumab plus ET [published online July 6, 2017]. J Clin Oncol. doi:10.1200/ JCO.2016.71.9815.
Lisa Schulmeister, MN, RN, ACNS-BC, FAAN
Lisa Schulmeister, MN, RN, ACNS-BC, FAANEditor-in-Chief, Oncology Nursing News® Oncology Nursing Consultant
When it binds HER2 receptors, the tumor cells internalize the drug along with the antigen—antibody complex. Inside the cells, trastuzumab is degraded and the cytotoxic agent emtansine is released, which promotes tumor cell death. .
Ado-trastuzumab emtansine is currently approved to treat patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. .
Ado-trastuzumab emtansine and trastuzumab are 2 different agents and should never be substituted for each another. In addition, clinicians who prescribe, prepare, and administer these agents need to be aware that they are “look-alike, sound-alike” agents and double check drug names to prevent medication errors. .
T-DM1 causes less toxicity than chemotherapy, including irreversible toxicities such as neurotoxicity. Consequently, it is being studied in neoadjuvant trials of women with early breast cancer. .
The West German Study Group ADAPT Trial is a prospective, randomized neoadjuvant phase II trial that compared T-DM1 with or without hormonal therapy versus trastuzumab with hormonal therapy. .
The trial was conducted specifically in women with hormone receptor-positive HER2-positive early breast cancer because the addition of another targeted anti-hormonal therapy represented a possible alternative to systemic chemotherapy. .
Prior studies suggested that T-DM1 may be as effective as standard therapy, which currently is chemotherapy plus anti-HER2 agents, and has fewer toxicities. .
Four cycles of neoadjuvant T-DM1 treatment yielded pathologic complete response rates comparable to standard chemotherapy plus trastuzumab. A pathologic complete response is generally defined as no residual histological evidence of cancer at the time of surgery. .
The ADAPT Trial findings suggest that T-DM1 neoadjuvant treatment is safe and effective, and has the potential to decrease treatment-induced toxicities and treatmentrelated costs.