ASCO 2021 Recap: Health-Related Quality of Life

ASCO Studies Cover Data on Health Care Utilization, Quality of Life

Dozens of studies presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting involved data measuring health care utilization, the costs of adverse events (AEs)
that result from cancer treatment, and patients’ quality of life.

Cost of Treatment-Related Diarrhea
Gastrointestinal AEs occur frequently in cancer treatment, especially when therapies are used in combination. Studies funded by Napo Pharmaceuticals, developer of a treatment to prevent noninfectious diarrhea, examined the cost of cancer-related diarrhea (CRD) to the health system and its effects on patients’ quality of life.^1,2 Led by Pablo C. Okhuysen, MD, of The University of Texas MD Anderson Cancer Center; Lee S. Schwartzberg, MD, of West Cancer Center; and Eric Roeland, MD, of Harvard Medical School, the studies examined 104,135 matched pairs of patients with either solid tumor or hematologic cancer, with and without CRD, who received chemotherapy or targeted therapy. Researchers used the IQVIA PharMetrics database to calculate all health care costs over a 12-month period, with the index date being the first cancer claim; patients were reindexed after the first claim based on treatment for diarrhea. Results showed that:

• Patients with CRD incurred significantly higher health care costs than those without: mean, $104,880 vs $39,664, respectively (P < .0001).
• Patients who had inadequate treatment for CRD had the highest mean health care costs, at $129,531; for patients treated adequately for CRD, mean costs were $107,050; and for patients who did not need treatment for CRD, mean costs were $56,350 (P for all comparisons, <.0001).
• Mean pharmacy costs were $35,190 for CRD patients compared with $15,883 for non-CRD patients; emergency department visits cost a mean of $1107 for CRD patients vs $431 for non-CRD patients.¹

Investigators also used the data set to gain insights about discontinuation rates by type of treatment for patients with and without CRD. Among patients receiving chemotherapy, those
with CRD stopped therapy more frequently than those without CRD: 81.5% vs 62.3%. Among patients taking a targeted therapy, those with CRD also stopped more frequently, but the gap was
not as large: 69.2% vs 64.3%. Discontinuation rates were highest for patients taking both treatments: 96% for those with CRD and 85.5% for those without (all P < .0001).²

More payers, including Medicare, are becoming interested in patient-reported outcomes for cancer therapies, and the FDA recently issued a guidance for industry on the topic.³

Cancer Raises Readmission Risk
Payment models such as the Oncology Care Model have sought to reduce the risk of hospital readmissions within 30 days of discharge. This outcome has been a priority across Medicare
under the Affordable Care Act, as such trips back to the hospital boost costs and are typically associated with poor patient outcomes. A study funded by the National Institutes of Health
sought to quantify how much having cancer elevated the 30-day readmission risk.⁴ Using the National Readmission Database, researchers identified nonprocedural hospital readmissions between January and November 2017 including those patients with and without a cancer diagnosis. Results showed that:

• Of 18.9 million weighted readmissions, 1.68 million (8.9%) involved patients who had a cancer diagnosis. A cancer diagnosis, vs no such diagnosis, was associated with a significantly higher risk of readmission: 23.5% vs 13.6% (P < .001).
• However, among readmissions, cancer patients were less likely to have a preventable readmission: 6.5% of readmissions of patients with cancer were seen as preventable, compared with 12.1% among patients without cancer, when both were readmitted for the same non–cancer-related
diagnoses (P < .001).
• The site of cancer was the greatest predictor of readmission risk. Patients with liver cancer, pancreatic cancer, and non-Hodgkin lymphoma had the highest readmission rates.

Perceptions Linked to End-of-Life Health Care Use
Patients who have an inaccurate view of their cancer prognosis will be unprepared to make difficult decisions regarding end-of-life care, which can lead to late treatment that will not be effective or to late hospital stays. Investigators funded by the Leukemia and Lymphoma Society conducted a secondary analysis using longitudinal data from a randomized controlled trial of a palliative care intervention for patients with incurable lung or gastrointestinal cancer.⁵

Using the Prognosis and Treatment Perceptions Questionnaire, they assessed patients at weeks 12 and 24 after diagnosis and conducted a final assessment close to death. There were 350 patients in the parent trial, of whom 80.5% died during the study period and were included in the analysis. Results showed that:

• 59.4% of the patients reported being terminally ill, while 66.1% said their cancer was likely curable at the assessment closest to death.
• The patients who said their cancer was curable were least likely to use hospice (OR, 0.25; 95% CI, 0.10-0.61; P = .002) or to die at home (OR, 0.56; 95% CI, 0.32-0.98; P = .043), and they were more likely to be hospitalized in the last 30 days of life (OR, 2.28; 95% CI, 1.20-4.32; P = .011).
• Patients who reported being terminally ill were less likely to be hospitalized in the last 30 days of life (OR, 0.52; 95% CI, 0.29-0.92; P = .025). However, these patients’ perceptions did not affect hospital length of stay or chemotherapy administration in the last 30 days of life.

References

1. Roeland E, Schwartzberg LS, Okhuysen PC, et al. Healthcare utilization and costs associated
with cancer-related diarrhea. J Clin Oncol. 2021;39(Suppl_15):abstr e18623. doi:10.1200/
JCO.2021.39.15_suppl.e18623
2. Okhuysen PC, Schwartzberg LS, Roeland E, et al. The impact of cancer-related diarrhea on
changes in cancer therapy patterns. J Clin Oncol. 2021;39(Suppl_15):abstr 12111. doi:10.1200/
JCO.2021.39.15_suppl.12111
3. FDA in brief: FDA provides guidance on measuring patient-reported outcomes in cancer
clinical trials. News release. FDA; June 9, 2021. Accessed July 3, 2021. https://www.fda.gov/
news-events/press-announcements/fda-brief-fda-provides-guidancemeasuring-patient-reported-
outcomes-cancer-clinical-trials
4. Qian A, Qiao E, Nalawade V, Kotha NV, Voora RS, Murphy JD. Impact of cancer on the risk of
unplanned 30-day readmissions. J Clin Oncol. 2021;39(Suppl_15):abstr 6581. doi:10.1200/
JCO.2021.39.15_suppl.6581
5. Topping CEW, Elyze M, Plotke R, et al. Association between perception of prognosis and endof-
life outcomes for patients with advanced lung and gastrointestinal cancer. J Clin Oncol.
2021;39(Suppl_15):abstr 6503. doi:10.1200/JCO.2021.39.15_suppl.6503

ASCO Clinical Spotlight: Kirk Shepard, MD, Highlights HRQOL Findings of Lenvatinib/Pembrolizumab Combination Therapy in Advanced Endometrial Carcinoma

KIRK SHEPARD, MD, chief medical officer, senior vice president, and head of Global Medical Affairs, Eisai, discusses findings of a study showcasing similar health-related quality of life scores of lenvatinib/pembrolizumab vs chemotherapy in patients with advanced endometrial carcinoma.

Results presented at the American Society of Clinical Oncology (ASCO) 2021 Virtual Annual Meeting showcased similar health-related quality of life (HRQOL) scores among patients with advanced
endometrial carcinoma (aEC) undergoing combination therapy vs monochemotherapy.¹ The findings could prove significantly important, particularly for a disease that has not had a specifically
approved therapy in 50 years, said Kirk Shepard, MD, chief medical officer, senior vice president, and head of Global Medical Affairs, Eisai.

EVIDENCE-BASED ONCOLOGY™ (EBO): Can you discuss what can be derived by measuring HRQOL for a condition such as endometrial cancer (EC), particularly in its advanced stages (aEC)?

SHEPARD: It’s extremely important that we measure these parameters in patients, particularly in endometrial carcinoma, and advanced endometrial carcinoma. It’s been 50 years since a drug has been specifically approved for endometrial carcinoma. It’s very important that we don’t just measure the effectiveness [and] efficacy of a drug, but also look at the risk-benefit balance, and of course quality of life is on the other side. So, the health-related quality of life measures, which have come quite far in the last couple of decades—including 2 guidelines, at least, written since 2006—[now inform] FDA about how they appropriately can measure quality of life in patients.

The particular one that we used, the [European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire], is the one that’s most used.² It’s…a general measure of parameters of different domains that has been validated in more than 100 validation studies
and used in maybe a couple thousand studies through a couple of decades. It’s very important that we use the tools that we have now to measure the quality of life in patients.

EBO: Results indicate similar mean HRQOL scores for patients with aEC undergoing the combination therapy vs chemotherapy. Can you speak on the significance of this finding?

SHEPARD: We were very happy with the results, as you might imagine, because we were comparing ourselves—Keytruda [pembrolizumab] and Lenvima [lenvatinib]—with one monochemotherapy. And these are traditional chemotherapies. It would be called the physician’s choice of
therapy, which is either doxorubicin or paclitaxel.

To come out with numerically the same—in fact, [actually] better,—although [the difference] wasn’t statistically [significant]—quality of life parameters as 2 mono drugs, while we’re giving 2 drugs, was
very important.

This is something very valuable because it gives [physicians]—particularly physicians who have treated endometrial carcinoma for 50 years with the same drugs—a window into what’s happening when we offer new advanced drugs, such as an [immuno-oncology] or a [tyrosine kinase inhibitor], such as Lenvima. It shows that, really, the QOL remains quite good. With the great results we got—[and] I think you’re probably familiar with the 309 Study we presented at the Society of Gynecologic
Oncology meeting]—it’s really a very acceptable risk-benefit ratio.³

EBO: Were there any notable differences by patient subgroup in HRQOL for those undergoing the combination therapy?

SHEPARD: It’s a great question, [but] we haven’t done subgroup analyses yet. That’s what needs to be done [next]. Of course, we wanted to get the topline results out for SGO as soon as we knew the results; [this way], treating physicians [would know] that this was another group of
drugs they could use together to treat patients.

Of course, the quality of life is somewhat topline now also. … But the subgroup analysis, as long as the numbers don’t get too low as we look at the group, is the way that we would want to go next as far as the next step.

It’s been a pleasure to work at a company like Eisai, because they have human health care. Human health care is a platform that was started 30 years ago, where we put the patient first, [and] the caregiver and the family. This fits in very well with what we’ve done, not only with endometrial
carcinoma, but in the same program at ASCO, we are doing a HRQOL study, and it’s being orally presented for renal cell carcinoma. So again, Eisai is very concerned about not just getting good results as far as shrinking tumors, but making sure that we always consider the quality of
life of the patient.

References

1. Lorusso D, Colombo N, Casado Herraez A, et al. Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC). J Clin Oncol. 2021;39(Suppl 15):abstr 5570. doi:10.1200/JCO.2021.39.15_suppl.5570
2. Quality of life group website. European Organization for the Research and Treatment of Cancer.
Accessed June 12, 2021. https://qol.eortc.org/
3. Keytruda (pembrolizumab) plus Lenvima (lenvatinib) significantly impr oved progression-free survival and overall survival versus chemotherapy in patients with advanced endometrial cancer following prior platinum-based chemotherapy in phase 3 study. News release. Merck; March 19, 2021. Accessed June 12, 2021. https://www.businesswire.com/news/home/20210319005069/en