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Thomas Gruenberger, MD, Shares Thoughts on Radiotherapy for Colorectal Liver Metastases

Invited discussant of the phase III EPOCH trial, Thomas Gruenberger, MD, a surgical oncologist at the Clinic Favoriten, Health Network Vienna, noted that the trial’s “intention was fulfilled,” thus making it the “first positive phase III trial that prolonged both progression-free and hepatic...

solid tumors

For Liver Metastases, Transarterial Radioembolization With Yttrium-90 Plus Chemotherapy May Delay Disease Progression

In the international phase III EPOCH trial, patients with colorectal liver metastases who experienced disease progression on first-line therapy derived significant benefit from treatment with transarterial yttrium Y-90 radioembolization in combination with systemic chemotherapy, according to Mary...

hematologic malignancies

Numerous Regimens Proposed for Relapsed or Refractory Myeloma

Although patients with multiple myeloma can respond to initial treatment, once a patient has had three or four different types of therapy, and the disease is deemed relapsed or refractory, treatment becomes more complicated. This is related to both clinical characteristics, as patients may develop...

prostate cancer

Use of Genomic Classifier Score May Help to Personalize Therapy for Men With High-Risk Prostate Cancer

A 22-genomic classifier (the Decipher score) was able to predict the course of disease in men with high-risk prostate cancer, according to a patient-level meta-analysis of three randomized clinical trials presented at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting.1 Use of...

head and neck cancer

De-escalation of Radiation Therapy for HPV-Positive, Intermediate-Risk Oropharyngeal Cancer

De-escalated adjuvant radiotherapy appears to be safe in patients with surgically resectable, human papillomavirus (HPV)--positive oropharyngeal cancers, particularly in patients without extranodal extension or pN2 disease by American Joint Committee on Cancer (AJCC) 8th edition. These findings...

Expert Point of View: Sophia C. Kamran, MD

Sophia C. Kamran, MD, a radiation oncologist at Massachusetts General Hospital and Assistant Professor of Radiation Oncology at Harvard Medical School, who was not involved in the RTOG 0815 study, commented: “The results of RTOG 0815 demonstrate that in the setting of contemporary dose-escalated...

prostate cancer

No Survival Benefit but Improved Secondary Endpoints With Radiotherapy Plus Androgen Suppression in Intermediate-Risk Prostate Cancer

Both dose-escalated radiation therapy and short-course androgen-deprivation therapy have been shown to improve outcomes in intermediate-risk prostate cancer, but it is not clear whether giving both modalities upfront to newly diagnosed patients is of benefit. The phase III RTOG 0815 study presented ...

breast cancer

BrighTNess: Neoadjuvant Carboplatin Improves Event-Free Survival in Triple-Negative Breast Cancer

In patients with early resectable triple-negative breast cancer, not only did the addition of carboplatin to standard neoadjuvant chemotherapy improve pathologic complete response rates, it also improved 4-year event-free survival, regardless of BRCA status, according to the latest analysis of the...

lung cancer

IMpower010: Adjuvant Atezolizumab Improves Disease-Free Survival and NSCLC Relapse in Patients Whose Tumors Express PD-L1

Adjuvant immunotherapy with atezolizumab after standard chemotherapy improved disease-free survival and time to locoregional and distant relapse compared with best supportive care in prespecified subgroups of patients with stage II to IIIA non–small cell lung cancer (NSCLC), according to an...

breast cancer

Risk-Reducing Medications for Breast Cancer Are Becoming Safer and More Tolerable

Risk-reducing medications for breast cancer may be effective for many women, and recently reported and ongoing trials have led to improvements in their tolerability and safety, Seema A. Khan, MD, reported at the 2021 Annual Lynn Sage Breast Cancer Symposium (virtual).1 Dr. Khan is Professor of...

breast cancer

Adjuvant Internal Mammary Node Irradiation in Node-Positive Breast Cancer

In a Korean phase III trial reported in JAMA Oncology, Kim et al found that the addition of internal mammary node irradiation to adjuvant regional nodal irradiation did not improve 7-year disease-free survival in women with node-positive breast cancer. In an ad hoc analysis, however, benefit was...

neuroendocrine tumors

Evidence for Efficacy of Sunitinib in Malignant Pheochromocytoma and Paraganglioma

Results from the phase II ­FIRSTMAPPP study support the potential use of the tyrosine kinase inhibitor sunitinib in two rare neuroendocrine malignancies—pheochromocytoma and paraganglioma. Sunitinib significantly improved the primary endpoint of progression-free survival vs placebo, according to...

lymphoma
head and neck cancer
solid tumors
genomics/genetics
gynecologic cancers
skin cancer
immunotherapy

FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...

covid-19

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children Aged 5 Through 11 Years

On October 29, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children aged 5 through 11 years. The authorization was based on the FDA’s thorough and transparent evaluation of the data that...

prostate cancer

Hypofractionated Postoperative Prostate Bed Radiotherapy Does Not Increase Patient-Reported Toxicity for Men With Prostate Cancer

A primary endpoint analysis of the NRG Oncology phase III NRG-GU003 clinical trial, which compared hypofractionated postoperative prostate bed radiotherapy (HYPORT) to conventional postprostatectomy radiotherapy (COPORT) for men with prostate cancer, determined that treatment with HYPORT yielded no ...

prostate cancer

Phase III Trial Evaluates Efficacy of Total Androgen Suppression Plus Dose-Escalated Radiotherapy for Patients With Intermediate-Risk Prostate Cancer

Both dose-escalated radiation therapy and short-course androgen-deprivation therapy (SADT) have been shown to improve outcomes in patients with intermediate-risk prostate cancer. Researchers then posed a new question—is giving both modalities upfront to newly diagnosed patients of benefit? Findings ...

colorectal cancer

FOCUS4-C Trial: Hint of Activity Reported With Adavosertib in Metastatic Colorectal Cancer

The novel WEE1 inhibitor adavosertib, given after induction chemotherapy, yielded a 65% reduction in the risk of disease progression or death compared with active monitoring in patients with metastatic colorectal cancer and TP53/RAS mutations, according to the randomized phase II FOCUS4-C trial....

colorectal cancer

KRAS G12C Inhibitor Adagrasib Shows Activity in Colorectal Cancer

Adagrasib, a covalent inhibitor of KRAS G12C, combined with cetuximab, showed activity in patients with metastatic colorectal cancer in the phase I/II KRYSTAL-1 trial, as presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2021 by Jared Weiss, MD,...

prostate cancer

22-Gene Classifier Score May Allow for Personalization of Therapy in Patients With High-Risk Prostate Cancer

A 22-gene genomic classifier (the Decipher score) may be able to predict the course of disease in men with high-risk prostate cancer, according to a patient-level meta-analysis of three randomized clinical trials presented by Paul L. Nguyen, MD, at the 2021 American Society for Radiation Oncology...

colorectal cancer

FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test,...

lung cancer

Pretreatment Levels of Circulating Tumor DNA May Predict Long-Term Survival in NSCLC

Pretreatment circulating tumor DNA (ctDNA) levels in patients with non–small cell lung cancer (NSCLC) appear to be a more accurate predictor of long-term survival than classic survival surrogates, according to research presented during the International Association for the Study of Lung Cancer...

lung cancer

Phase II Trial Finds Atezolizumab of Benefit in Patients With Lung Cancer and Brain Metastases

Patients with non–small cell lung cancer (NSCLC) and brain metastasis derived significant benefit from treatment with the monoclonal antibody atezolizumab plus chemotherapy, according to the multicenter phase II Atezo-Brain trial.1 The study was presented at the International Association for the...

prostate cancer

STAMPEDE: In Nonmetastatic Castration-Sensitive Prostate Cancer, Abiraterone Added to Androgen-Deprivation Therapy Improves Survival

The addition of 2 years of abiraterone acetate plus prednisolone (AAP) to androgen-deprivation therapy improves metastasis-free survival and overall survival compared with androgen-deprivation therapy alone in men with nonmetastatic castration-sensitive prostate cancer, according to a primary...

Expert Point of View: Florian Lordick, MD, PhD

Florian Lordick, MD, PhD, Professor of Oncology and Director of the University Cancer Center Leipzig, Germany, applauded the positive finding for nivolumab plus chemotherapy in CheckMate 6491 and questioned why nivolumab plus ipilimumab did not meet its endpoint. “I’m calling this a big step...

solid tumors

CheckMate 649: Long-Term Data Support Nivolumab Plus Chemotherapy but Not Nivolumab Plus Ipilimumab in Gastric Cancer

Longer follow-up data from the phase III CheckMate 649 trial support the use of nivolumab plus chemotherapy as a new standard first-line regimen in patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The findings were reported by Yelena Janjigian, ...

skin cancer
genomics/genetics
immunotherapy

SECOMBIT Trial Evaluates Optimal Treatment Sequencing in BRAF-Mutated Melanoma

Patients with untreated, metastatic BRAF-mutated melanoma may benefit from receiving immunotherapy first, moving to targeted therapy in the second line, data from the updated overall survival analysis of the randomized, phase II SECOMBIT trial suggest.1 The study aimed to define the optimal...

breast cancer
immunotherapy

Another Antibody-Drug Conjugate Enters the Metastatic Breast Cancer Landscape

In the global phase III TULIP trial in metastatic HER2-positive breast cancer, treatment with the antibody-drug conjugate vic-trastuzumab duocarmazine (SYD985) significantly improved progression-free survival in comparison with standard chemotherapy in previously treated patients, making this a new ...

Expert Point of View: Enrique Grande, MD

Invited discussant Enrique Grande, MD, of the Medical Oncology Department at MD Anderson Cancer Center Madrid, said that the VESPER trial should really be regarded as a neoadjuvant trial, since 88% of the patients enrolled were treated in the neoadjuvant setting. He focused the rest of his remarks ...

bladder cancer

Neoadjuvant dd-MVAC Improves Local Control and Progression-Free Survival in Patients With Muscle-Invasive Bladder Cancer

The VESPER phase III trial answers some key questions regarding the optimal management of muscle-invasive bladder cancer. The study found that the neoadjuvant regimen of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) was superior to standard gemcitabine/cisplatin in...

breast cancer

MONALEESA-2: Overall Survival Benefit With First-Line Ribociclib Plus Letrozole

Ribociclib plus hormonal therapy in the first-line setting boosted overall survival by more than 1 year, vs hormone therapy alone, in postmenopausal women with hormone receptor–positive HER2-negative advanced breast cancer, according to the latest findings from the MONALEESA-2 trial, reported at...

sarcoma

Activity of Nab-sirolimus in Malignant Perivascular Epithelioid Cell Tumors

In the phase II AMPECT trial reported in the Journal of Clinical Oncology, Wagner et al found that the mTOR inhibitor nab-sirolimus produced a substantial rate of durable responses and a high disease control rate in patients with malignant perivascular epithelioid cell tumors. As stated by the...

gynecologic cancers

PARP Rechallenge Slows Ovarian Cancer Progression in Platinum-Sensitive Disease

Rechallenge with the poly (ADP-­ribose) polymerase (PARP) inhibitor olaparib in patients with platinum-sensitive ovarian cancer led to significant improvement in progression-free survival, in patients with either BRCA1/2-mutated or nonmutated (ie, wild-type) disease compared with placebo, according ...

colorectal cancer

Primary Tumor Resection Followed by Systemic Treatment vs Systemic Treatment Alone in Metastatic Colorectal Cancer: 60-Day Mortality

As reported in JAMA Surgery by van der Kruijssen et al, 60-day post–random assignment mortality results in the Danish/Dutch phase III CAIRO4 trial showed higher rates of mortality in patients with metastatic colorectal cancer who received primary tumor resection plus systemic treatment vs those...

gynecologic cancers
immunotherapy

FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer

On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...

breast cancer

KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer

Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...

breast cancer

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...

Expert Point of View: Melinda L. Telli, MD

The invited discussant of GeparNuevo,1 Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University School of Medicine, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, welcomed the additional data...

breast cancer

Neoadjuvant Durvalumab Improves Long-Term Outcomes in the GeparNuevo Trial

In the phase II GeparNuevo trial, patients with early triple-negative breast cancer receiving the PD-L1 inhibitor durvalumab in addition to chemotherapy as neoadjuvant therapy saw improvements in long-term outcomes. The results were presented at the 2021 ASCO Annual Meeting by Sibylle Loibl, MD,...

Expert Point of View: Giuseppe Curigliano, MD, PhD

Invited discussant Giuseppe Curigliano, MD, PhD, Associate Professor of Medical Oncology at the University of Milan, Italy, and Head of the Division of Early Drug Development at the European Institute of Oncology, said the “clear” findings of KEYNOTE-5221 are “practice-changing.” However, the ideal ...

breast cancer

KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer

The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...

breast cancer

Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?

Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....

breast cancer

ADAPT Trial: ‘Excellent’ Outcomes Reported With Neoadjuvant Dual HER2 Therapy in Breast Cancer

The first overall survival analysis of the WGS-ADAPT HER2+/HR– study, which evaluated neoadjuvant therapy in patients with hormone receptor–negative, HER2-positive disease, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or with the chemotherapy-free regimen of...

breast cancer

Long-Term Analysis of Short-HER Trial of Adjuvant Trastuzumab

Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...

breast cancer

Novel HER2-Targeted Therapies Pose Sequencing Challenges

With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...

breast cancer

Expert Point of View: C. Kent Osborne, MD

C. Kent Osborne, MD, Founding Director of the Dan L. Duncan Comprehensive Cancer Center and the Dudley and Tina Sharp Chair for Cancer Research, Baylor College of Medicine, Houston, said in a press briefing that the results of the study were clear, but the explanation for the findings is less so....

breast cancer

A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer

The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...

breast cancer
genomics/genetics

OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer

Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...

breast cancer

Beyond CDK4/6 Inhibitors in Metastatic Breast Cancer: What’s Next?

Because of their well-established efficacy, inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) are the standard of care in the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer. The question now is this: After disease progresses on a CDK4/6 inhibitor and endocrine...

prostate cancer

PEACE-1: Abiraterone Plus Androgen-Deprivation Therapy and Docetaxel Boosts Survival in Metastatic Castration-Sensitive Prostate Cancer

The addition of abiraterone acetate plus prednisone on top of androgen-deprivation therapy plus docetaxel improved survival in patients with de novo metastatic castration-sensitive prostate cancer vs androgen-deprivation therapy plus docetaxel alone. These results were from the phase III PEACE-1...

lung cancer

Expert Point of View: Charles M. Rudin, MD, PhD

Charles M. Rudin, MD, PhD, Hassenfeld Professor and Chief of the Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, commented that although ATLANTIS1 “unfortunately joins the ranks of negative phase III studies in patients with recurrent small cell lung cancer,” there are “some...

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