It’s the Best of Times and Worst of Times for Cancer Care in Tampa

A bumper crop of oncology and hematology approvals, along with rapidly changing clinical guidelines, means physicians have more choices than ever to discuss with patients diagnosed with cancer. But demographic shifts in Central Florida, along with payer barriers, are making access to care more challenging, putting new therapies just out of reach for many, according to clinicians appearing across 4 panels on September 1, 2026, at the Grand Hyatt Tampa Bay in Tampa. Faculty from Moffitt Cancer Center, Tampa General Hospital (TGH), Florida Cancer Specialists & Research Institute (FCS), and the University of South Florida (USF) joined the discussions.

Moffitt Breast Oncologists Weigh Lung Toxicity and Sequencing as Approvals Pile Up

Moderator Ricardo Costa, MD, MSc, led colleagues from Moffitt Cancer Center in the first panel, “Targeted Success: Operationalizing Therapies in Breast Cancer,” by counting the breast cancer approvals and label changes of the past 12 to 18 months. “I think I stopped counting at No. 6, so we have a lot to talk about,” he said.

Early-stage HER2-positive disease. In DESTINY-Breast11 (NCT05113251), presented in October 2025 during the European Society for Medical Oncology (ESMO) Congress,¹ 4 cycles of trastuzumab deruxtecan (T-DXd; Enhertu; AstraZeneca), followed by paclitaxel, trastuzumab (Herceptin), and pertuzumab (Perjeta), produced a pathologic complete response (pCR) rate of 67%. Costa said the rate reached 83% in estrogen receptor–negative disease. Kathrin Dvir, MD, MSc, called the pCR rates “unprecedented” and noted that the label covers more patients than the trial enrolled.

Hatem Soliman, MD, said interstitial lung disease (ILD), which clinicians have become more adept at managing, is fatal in fewer than 1% of patients. “But it’s enough that it gives you pause about treating people with lower-risk disease than what was originally enrolled in the trial,” he said. Avan Armaghani, MD, said her monitoring is based on symptoms: “If patients are coming in with new respiratory symptoms, even if they’re very mild, we’re holding the drug, and we’re getting imaging.”

In DESTINY-Breast05 (NCT04622319), also presented at ESMO 2025, patients with residual disease received 14 adjuvant cycles of T-DXd. Costa cited an ILD rate of 9.6%.² “I’d rather give it in the neoadjuvant setting with 4 cycles, where the risk of ILD is substantially lower than the 14 cycles,” Dvir said.

Asked what to give when disease remains after neoadjuvant T-DXd, Soliman said: “That’s the million-dollar question.… We don’t know the optimal sequence.” He pointed out that the DESTINY-Breast11 arm giving T-DXd alone closed for futility, which suggests that “switching to different [mechanism-of-action] drugs may be actually more important.” He generally turns to trastuzumab emtansine.

Metastatic disease. With the DESTINY-Breast09 regimen (NCT04784715),³ presented at the American Society of Clinical Oncology (ASCO) 2025 annual meeting, Soliman uses first-line T-DXd plus pertuzumab for aggressive disease. “The big question for all of us is figuring out how to de-escalate properly off of that, because there’s no exit ramp,” he said.

The PATINA regimen (NCT02947685) uses the maintenance oral kinase inhibitor palbociclib (Ibrance; Pfizer) with anti-HER2 and endocrine therapy. Approved in June 2026,⁴ it produced a median progression-free survival of 44.3 months. “That’s not their overall survival. That’s just median time until they progress,” Dvir said. “It’s something we could have just dreamed about a few years ago.”

For hormone receptor (HR)–positive patients, she induces with T-DXd plus pertuzumab and then switches to PATINA maintenance. Costa chooses based on how much disease is present and where. For less bulky, bone-predominant disease, he considers PATINA. “We usually see patients with visceral disease, more aggressive. They’re uncomfortable. You’ve got to shrink the tumor,” he said. Tucatinib (Tukysa; Pfizer) maintenance from the HER2CLIMB-05 trial (NCT05132582) was approved October 7, after the meeting.⁵

Other recent approvals. Soliman said datopotamab deruxtecan (Datroway; Daiichi Sankyo/AstraZeneca), approved in first-line triple-negative breast cancer (TNBC) in May,⁶ and sacituzumab govitecan (Trodelvy; Gilead), approved in June,⁷ show similar activity in PD-L1–negative TNBC, which means “you have to personalize the choice.” Sacituzumab causes more gastrointestinal toxicity and bone marrow suppression. Datopotamab causes more eye toxicity and mouth sores. Moffitt partners with local ophthalmologists, Armaghani said, because “eye care, surprisingly, is hard to access.”

Gedatolisib (Revtorpyk; Celcuity) was approved in July for HR-positive/HER2-negative advanced PIK3CA wild-type disease.⁸ Dvir called this “a very robust agent” but cautioned that “the [adverse] effect profile is not benign,” especially in the triplet with fulvestrant and palbociclib. Soliman said Medicare patients who need oral endocrine agents often rely on foundation support that “may not be sufficient.”

Hematology Experts Call for Trials and Payer Policies That Reflect Real-World Patients

Faculty from Moffitt and TGH discussed trial eligibility, delays in insurance coverage, site-of-care rules, and the informal ties that support shared care.

Trials that look like the clinic. “Many of the eligibility trial criteria are actually set up basically to select the best patients for the results,” said Rami S. Komrokji, MD, of Moffitt. He described an earlier study with The University of Texas MD Anderson Cancer Center that reversed the usual criteria. Patients who would normally have been excluded “draw survival advantage from going on the clinical trial.”

Megan Melody, MD, MS, also from Moffitt, said real-world data have reshaped chimeric antigen receptor (CAR) T-cell therapy eligibility. “We can do CAR T-cell therapy in patients who are on dialysis. We can do CAR T-cell therapy in patients who are over the age of 80,” she said. Ankit Kansagra, MD, of TGH, said the FDA recently signaled that phase 3 trials should not exclude patients because of performance status or reduced creatinine clearance.⁹ “Myeloma is the disease I take care of. Everybody has chronic kidney disease,” he said.

Early CAR T-cell therapy protocols required patients to stay within 30 minutes of the center. “In Florida, 30 minutes doesn’t get you [very] far,” Kansagra said. Moffitt’s Javier Pinilla-Ibarz, MD, PhD, said access remains the central barrier. “One of the very critical aspects of the cellular therapies is to be able to access a center that’s able to deliver this therapy.”

Payers and the guideline gap. Pinilla-Ibarz said it’s common for insurers to deny coverage for newly approved drugs outright. “They say, well, what are you talking about? They reject immediately.” Melody said she once spent “6 weeks on the phone with [an] insurance company for this one particular patient.” She noted that nivolumab plus doxorubicin, vinblastine, and dacarbazine for Hodgkin lymphoma was used for about 2 years before FDA approval, and coverage had to be argued based on inclusion in guidelines from the National Comprehensive Cancer Network (NCCN), which is supposed to be the “gold standard” for payers. Kansagra said some Florida insurers now bar about a dozen drugs, including daratumumab (Darzalex; Janssen), from hospital-based infusion sites.

Closing the community gap. Kansagra cited a comparison from public health leader Atul Gawande, MD, MPH: The Cheesecake Factory can put a new recipe into every location within weeks, but a new FDA approval takes approximately 10 years to reach routine use nationwide. “It’s horrifying if you think about that number,” Kansagra said. “We can do better, and we should do better.” Komrokji added that for community practices, “reimbursement is a huge issue.”

For patients who have a complex procedure, such as CAR T-cell therapy, at Moffitt but live far away, Pinilla-Ibarz said, “We always make them have a community oncologist close by.” Kansagra said Foundation for the Accreditation of Cellular Therapy guidance now lets community partners take over follow-up monitoring, although the required 15-year reporting to the Center for International Blood and Marrow Transplant Research registry is hard to meet for “snowbirds,” those patients who only live in Florida during winter months. Melody said coordination often depends on whether colleagues have “my cell phone number or my personal email.”

Outpatient CAR T-cell therapy will require more than educating oncologists, Melody said. “It’s having an [electronic health record] that can recognize CRS [cytokine release syndrome] and ICANS [immune effector cell–associated neurotoxicity syndrome],” she said. “It’s having an [intensive care unit] that knows how to manage CRS and ICANS.”

Snowbirds, Staffing, and Special Challenges of Florida

Katherine Tobon, PharmD, BCOP, an advanced clinical pharmacy specialist in malignant hematology at Moffitt, moderated “Cancer Care in the Sunshine State: Addressing Needs in a Rapidly Changing Region.” She opened by noting that Florida’s population is rapidly growing and also shifting.

“We’re [seeing] a disproportionately much larger older population, especially our patients greater than 65 years of age,” she said. The question is how “that demographic surge is translating into the oncology patient volume.”

Vani N. Simmons, PhD, assistant center director of Moffitt’s Office of Community Outreach and Engagement (COE), said the 23-county catchment area that supplies most of Moffitt’s patients has a larger share of residents older than 65 years than Florida or the US as a whole. This shapes outreach: COE takes prevention education and mobile screening directly to senior centers.

The demographic and rural-urban shifts are visible in clinic, said Logan Murray, PA-C, of TGH, who described rising volumes of myelodysplastic syndromes and acute myeloid leukemia (AML) among older patients who are historically harder to treat.

“Florida is an incredibly diverse state. It’s not all beaches and Disney. There are a lot of rural pockets spread throughout. We get a lot of patients who live no more than an hour away, but it’s almost a completely different country because of the resources that they have,” he said. “We see patients with limited resources at their disposal, and we’re really grateful to our community oncologist partners who are able to refer these patients to us, so that we can get involved with their care.”

Seasonal residents add another layer. Patients who split their time between states must secure authorizations in 2 places, which Murray said can cause harm when delays allow aggressive blood cancers to advance. Tobon said her clinic was already planning winter transitions on September 1, including where specialty drugs will be shipped.

Murray said all-oral regimens in AML and chronic myeloid leukemia offer patients better quality of life, but prior authorization delays and out-of-pocket costs can stifle access. “The financial toxicity component is [an adverse] effect just as much as cytopenias and hair loss,” he said, describing patients forced to choose between venetoclax (Venclexta; AbbVie/Genentech) and rent. Simmons added that caregiver burden, including whether family members can keep working, is an often-overlooked part of financial toxicity.

Workforce and artificial intelligence (AI). On staffing, Tobon said flexible and hybrid schedules, telehealth visits, and sign-on bonuses are now part of recruiting pharmacists and advanced practice providers (APPs). Murray said TGH has grown from single digits to approximately 45 APPs in roughly 3 years, but slow onboarding and credentialing can prolong burnout. Simmons described hiring community health educators who live in the counties they serve and building a pipeline through programs that start in middle school and extend to postdoctoral training in behavioral oncology.

Murray said AI tools at TGH condense lengthy charts into a few paragraphs, assist with documentation, and support an AI-based tumor board for complex cases. He said AI has cut the time needed to draft letters of medical necessity from 30 to 45 minutes to under a minute, with careful proofreading. Still, he said patients often arrive with answers they’ve pulled from ChatGPT, and clinicians must be transparent that AI informs but does not dictate care. Simmons urged that communities be included in conversations about AI to address mistrust and ensure tools work across populations, and noted its potential to map cancer burden in real time.

Drug shortages. Tobon highlighted ongoing shortages of low-margin generics such as ifosfamide and carboplatin, often used with curative intent. Moffitt relies on a dedicated shortage team and 2 supply reserve programs that aim to guarantee approximately 6 months of key generics; community patients sometimes must transfer to Moffitt to receive scarce drugs. Murray said TGH has come “painfully close” to running out and has worked creatively, including sourcing generics through Mark Cuban’s Cost Plus Drug Company.

In Lung Cancer, Test Everyone, as Early as Possible

Christopher Elder, PharmD, associate director of pharmacy clinical services at FCS, moderated “Precision in Practice: Implementing Biomarker Testing in Lung Cancer.” He pointed to the growing list of roughly 15 standard targets and recent data, including adjuvant selpercatinib (Retevmo; Lilly) in the LIBRETTO-432 trial¹⁰ (NCT04819100) and 7-year results from the CROWN trial (NCT03052608), in which patients who were progression free on lorlatinib (Lorbrena; Pfizer) at 2 years had about an 80% chance of remaining progression free at 7 years.¹¹

Sonam Puri, MD, a thoracic medical oncologist at Moffitt with an appointment at USF, said the protocol is now straightforward. “Test everybody as soon as you can with comprehensive panel testing.” For metastatic disease, she recommends tissue plus liquid biopsy, or sequential testing if one test is negative; for early-stage disease, tissue comes first because circulating tumor DNA can yield false negatives. RNA sequencing is essential in patients who have never smoked.

J. Kevin Hicks, PharmD, PhD, FCCP, who directs pharmacogenomics at Moffitt, said a recommendation from ASCO, now released, calls for next-generation sequencing in all patients with stage IB to IV disease,¹² with comprehensive testing, including RNA sequencing and targetable immunohistochemistry for MET, HER2, and ALK.

Building the workflow. Puri said she has not faced payer denials for Moffitt’s standard panel. The bigger issues are time and tissue. Moffitt’s thoracic reflex testing order lets pathologists send samples for molecular testing immediately, saving 2 to 5 days. Hicks described Moffitt’s precision medicine service, which compiles results, writes consult notes that travel with patients back to community oncologists, and runs a monthly virtual molecular tumor board with Memorial Healthcare System in South Florida.

Getting results from outside testing sources, by contrast, remains a pain point. Puri said genomic reports must be requested specifically or they are missed, and she praised cross-institutional access to FCS records. Hicks noted that Moffitt’s move from Cerner to Epic may change how in-house results flow, while Elder said FCS is moving to iKnowMed. Elder and Hicks also flagged inconsistent reference lab formats; Hicks described a case in which a liquid biopsy showed a BRAF V600E mutation but a methylation signature suggested an ALK-driven cancer.

Regarding guidelines, Puri, who serves as cochair of the ASCO non–small cell lung cancer guideline, explained that the NCCN offers consensus-based algorithms while ASCO’s living guideline is updated every 3 months. ASCO and the NCCN are in alignment on biomarker testing, she said. “There is absolutely no doubt that both institutions recommend comprehensive molecular testing.”

References

1. Harbeck N, Modi S, Pusztai L, et al; DESTINY-Breast11 Trial Investigators. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase III trial. Ann Oncol. 2026;37(2):166-179. doi:10.1016/j.annonc.2025.10.019
2. Loibl S, Park YH, Shao Z, et al; DESTINY-Breast05 Trial Investigators. Trastuzumab deruxtecan in residual HER2-positive early breast cancer. N Engl J Med. 2026;394(9):845-857. doi:10.1056/NEJMoa2514661
3. Tolaney SM, Jiang Z, Zhang Q, et al; DESTINY-Breast09 Trial Investigators. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med. 2026;394(6):551-562. doi:10.1056/NEJMoa2508668
4. Hohmann E. FDA approves palbociclib for HR+, HER2+ breast cancer maintenance. AJMC. June 24, 2026. Accessed October 14, 2026. https://www.ajmc.com/view/fda-approves-palbociclib-for-hr-her2-breast-cancer-maintenance
5. McNulty R. FDA approves tucatinib maintenance for HER2+ metastatic breast cancer. AJMC. October 7, 2026. Accessed October 14, 2026. https://www.ajmc.com/view/fda-approves-tucatinib-maintenance-for-her2-metastatic-breast-cancer
6. Hohmann E. Datopotamab deruxtecan wins first-line FDA approval for immunotherapy-ineligible triple negative breast cancer. AJMC. May 22, 2026. Accessed October 14, 2026. https://www.ajmc.com/view/datroway-wins-first-line-fda-approval-for-immunotherapy-ineligible-triple-negative-breast-cancer
7. Hohmann E. FDA approves sacituzumab govitecan-hziy for first-line metastatic triple-negative breast cancer. AJMC. June 25, 2026. Accessed October 14, 2026. https://www.ajmc.com/view/fda-approves-sacituzumab-govitecan-hziy-for-first-line-metastatic-triple-negative-breast-cancer
8. Grossi G. FDA approves gedatolisib for HR+/HER2- advanced breast cancer. AJMC. July 15, 2026. Accessed October 14, 2026. https://www.ajmc.com/view/fda-approves-gedatolisib-for-hr-her2--advanced-breast-cancer
9. Hartley-Brown M, Cole CE, Price P, et al. Creating equitable and inclusive clinical trials for multiple myeloma. Clin Lymphoma Myeloma Leuk. 2024;24(1):32-39. doi:10.1016/j.clml.2023.09.004
10. Wu YL, Hochmair M, Yang Y, et al; LIBRETTO-432 Trial Investigators. Selpercatinib in early-stage RET fusion-positive non-small-cell lung cancer. N Engl J Med. 2026;395(7):660-670. doi:10.1056/NEJMoa2602628
11. Shaw AT, Solomon BJ, Felip E, et al. Lorlatinib versus crizotinib as first-line treatment for advanced ALK-positive non-small-cell lung cancer: 7-year update from the phase III CROWN study. Ann Oncol. 2026;37(9):1242-1252. doi:10.1016/j.annonc.2026.05.692
12. Price PW, Ismaila N, Blanco AC, et al. Therapy for stage IV non-small cell lung cancer with driver alterations: ASCO Living Guideline, v2026.3.3, July 24, 2026. J Clin Oncol. 2026;44(7):e15-e55. doi:10.1200/JCO-25-02822