Research & Clinical Trials

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Research & Clinical Trials > Research Findings > 2018 ASCO New Treatment Insights


New Treatment Insights: Highlights from the 2018 American Society for Clinical Oncology Annual Meeting

by Piri Welcsh, PhD

Less is more when it comes to Herceptin

Take home

HER2-positive breast cancer patients can safely shorten treatment with Herceptin (trastuzumab).

In-depth summary

Margaret Earl from the University of Cambridge presented results of the PERSOPHONE trial that looked at a shorter course of trastuzumab.

The trial included 4,088 women from 152 sites in the U.K. enrolled between 2007 and 2015. All patients were prescribed chemotherapy. Participants were randomly assigned to receive 6 months (2,043 patients) or 12 months (2,045 patients) of trastuzumab.

Disease-free survival the length of time after primary cancer treatment ends without any signs or symptoms of that cancer was the primary end point. After 4 years of treatment, results were similar for both groups: 89.4% of patients in the 6-month group and 89.9% in the 12-month group were free of disease. Secondary endpoints included overall survival and heart function. Overall survival was 93.8% in the 6-month group and 94.8% in the 12-month group. Both groups recovered heart function, but patients who received a shorter course of trastuzumab did so more quickly.

This trial also revealed another important finding. Patients who had the shorter treatment cycle less often discontinued the medication because of damage to the heart muscle: 8% of those in the 12-month group and 4% in the 6-month group stopped treatment due to cardiotoxicity. Analysis of quality of life experiences and economic impact are ongoing.

These results are a first step in reducing treatment time for women with HER2-positive breast cancer. However, whether or not patients would accept a slight reduction in disease-free survival in return for the benefits of shorter treatment with trastuzumab remains to be determined.

MRI screening as an alternative to risk-reducing mastectomy

Take Home

For some BRCA mutation carriers, MRI-based breast cancer screening may be an alternative to risk reducing mastectomy.

In-depth summary

A poster by Ellen Warner, MD, from the University of Toronto presented the extended results of the Toronto MRI Screening Study, which looked at MRI screening as an alternative to risk-reducing mastectomy.

While the short-term risk of recurrence in previously diagnosed breast cancer patients who opt for breast conservation therapy (lumpectomy followed by radiation) is similar for carriers and non-carriers. The risk of late new breast primaries may be substantially higher for carriers.

To better understand this risk, researchers followed 380 women from 1997 to 2009 who had BRCA mutations and no history of breast or ovarian cancers. All of the women had 9 rounds of annual breast screening using MRI and mammography. During this time, a total of 41 cancers 30 of which were invasive were detected in 40 women. (20 with BRCA1 mutation and 20 with BRCA2 mutation).

Of these, 27 (68%) chose breast conservation, 7 (18%) had a unilateral mastectomy and 6 (15%) chose bilateral mastectomy. The 40 women diagnosed with breast cancer were then surveyed annually to determine risk of late recurrence and survival. As of June 2018, the median follow-up time was 14 years.

  • Of the 40 women diagnosed with breast cancer in the study:
  • 4 (85%) are alive with no evidence of disease.
  • Six have died:
  • 2 (5%) of peritoneal cancer (cancer of the abdominal lining),
  • 1 of ovarian cancer,
  • 1 of suicide, and
  • 2 (5%) of estrogen receptor-positive breast cancer, with distant recurrences 6 and 7 years after diagnosis.
  • Among the 27 women who had breast conservation therapy after diagnosis:
  • 6 (22%) had a recurrence/new primary in the previously diagnosed breast that occurred at 3, 3, 6, 15, 16 and 19 years.
  • 1 had breast cancer in the opposite breast at 1 year.
  • Ten-year breast cancer-specific survival was 94.6% for all 40 patients and 92.6% for the 2 patients diagnosed with invasive disease.

In this study, distant recurrences occurred relatively early after initial treatment. While small, this study also suggests that MRI-based breast screening may be a reasonable alternative to risk-reducing mastectomy.

Two leaps forward for pancreatic cancer

Take home

Using chemotherapy in new ways can improve outcomes for some pancreatic cancer patients.

In-depth summary

Two new clinical trials reported that using chemotherapy in new ways can significantly extend the lives of patients with pancreatic cancer, one of the deadliest cancers known.

The results of the first trial, PREOPANC, suggest that chemoradiotherapy chemotherapy and radiation therapy delivered before surgery improves outcomes for patients with pancreatic cancer tumors that can be partially or fully removed by surgery.

A total of 246 patients with partially or fully removable pancreatic cancer were randomly assigned to one of two treatment regimens:

  1. Immediate exploratory surgery followed by 6 cycles of the current standard of care, the chemotherapy drug gemcitabine (Gemzar) (127 patients), or
  2. 1 cycle of neoadjuvant gemcitabine, then radiotherapy, another cycle of gemcitabine, and then surgery followed by 4 more cycles of gemcitabine (119 patients).

Median overall survival was 13.7 months with immediate surgery and 17.1 months with treatment before surgery. Although these results are preliminary, they suggest that treatment before surgery has benefit over immediate surgery.

One of the complications with pancreatic cancer is that the blood vessels running underneath the pancreas towards the liver are essential to life. Pancreatic cancer can involve these vessels, and prohibit tumor removal. Treatment before surgery allowed doctors to completely remove the tumor in 63% of patients compared to 31% of patients who had no such treatment before surgery. This trial is still ongoing.

In the PRODIGE 24 trial, a 4-drug chemotherapy "cocktail" extended the lives of patients who had surgery by nearly 2 years over the standard single-drug chemotherapy regimen for pancreatic cancer. Because the prognosis for pancreatic cancer patients is generally poor, this study is important; it showed that overall survival can be extended from just under 3 years to almost 5 years.

The study followed 493 pancreatic patients who, shortly after surgery (between 3 and 12 weeks), randomly received either:

  • gemcitabine (Gemzar) the current standard chemotherapy drug for this cancer

or

  • mFOLFIRINOX a modified form of FOLFIRNOX-a combination of drugs that is commonly used to treat metastasized pancreatic cancer that includes oxaliplatin (Eloxatin), irinotecan (Camptosar), and 5-fluorouracil (Adrucil). This modified combination therapy includes folinic acid (Leucovorin) that protects against chemotherapy side effects.

Average overall survival was slightly more than 54 months with the mFOLFIRINOX compared to 35 months with the single drug. mFOLFIRINOX also nearly doubled the time before recurrence (almost 22 months compared to nearly 13 months), and metastasis to other organs (around 30 months versus 17 months).

mFOLFIRINOX will likely now become standard of care for patients with resected pancreatic cancer. However, it is not without a downside. About three-quarters of patients who took it during the trial had severe side effects, compared to about half of those who took gemcitabine alone.

Pancreatic cancer is difficult to detect it is rarely found in its earliest stages and to treat. Together, these two studies offer hope to pancreatic cancer patients and show that treatment before and after surgery can extend their lives. Researchers will now likely look at combining these two trial approaches to see if patients benefit from treatments before and after surgery that includes a 4-drug combo.

posted 8/18/2018

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