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Oncología Parte 1
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Oncology High Value Care Recommendations ‘The American College of Physicians, in collaboration with multiple other organizations, is engaged in a worldwide initiative to promote the practice of High Value Care (HVC). The goals of the HVC initiative are to improve health care outcomes by providing care of proven benefit and reducing costs by avoiding unnecessary and even harmful interventions. The initiative comprises several programs that integrate the important concept of health care value (balaneing clinical benefit with costs and harms) for a given intervention into a broad range of educational materials to address the needs of trainees, practicing physicians, and patients. HVC content has been integrated into MKSAP 19 in sev- eral important ways. MKSAP 19 includes HVC-identified key points in the text, HVC-focused multiple-choice ques- tions, and, in MKSAP Digital, an HVC custom quiz. From the text and questions, we have generated the following, list of HVC recommendations that meet the definition below of high value care and bring us closer to our goal of improving patient outcomes while conserving finite High Value Care Recommendation: 4 recommendation to choose diagnostic and management strategies for patients {in specific clinical situations that balance clinical benefit with cost and harms with the goal of improving patient outcomes. Below are the High Value Care Recommendations for the Oncology section of MKSAP 19. + Imaging studies such as PET, CT, or bone sean for staging are not recommended in asymptomatic patients with newly diagnosed stage 0 to II breast cancer, + Surveillance blood tests and other imaging tests for breast ‘cancer should not be routinely performed and should be guided by a patient’s symptoms or findings on examina- ton that raise concern for recurrence. Neither radiation therapy nor hormonal therapy provides benefit ater bilateral mastectomy for patients with ductal carcinoma in situ (see Item 70). * Multigene recurrence assays or gene expression profiles have dramatically improved the ability to avoid chemo- therapy for patients at low risk of recurrence who will not benefit from chemotherapy and to identify patients at greater risk who do benefit from chemotherapy (see Item 45). Consensus guidelines indicate that pregnancy after breast cancer should not be discouraged (see Iter 16). + Second-look laparotomy to assess pathologic response following chemotherapy of ovarian cancer should not be performed, Annual cervical or vaginal cytology should be done on all cervical cancer survivors; additional surveillance imaging and laboratory studies for cervical cancer survivors are recommended only if there are signs or symptoms sug gestive of recurrence, ‘+ PET scans should not be used for preoperative staging or postoperative surveillance in colorectal cancer. PET scans do not add value in the staging of pancreatic cancer and are not part of standard management, Well-differentiated neuroendocrine tumors are indolent and often initially only require observation and serial Imaging. ‘Anal cancer is often curable with combined irradiation, and chemotherapy; surgery is typically not indicated (Gee Item 22). Patients with poor performance status and advanced ‘non-small cell lung cancer without a driver mutation do ‘not benefit from chemotherapy nor immunotherapy and are best served with supportive care (see Item 25) + Routine imaging for head and neck cancer after a nega- tive posttreatment scan Is not indicated unless signs and symptoms suggest recurrent disease, Although patients who receive radiation therapy that includes the thyrold bed are at increased tisk of thyroid ‘cancer, screening thyroid ultrasonography is not Indicated In men with low-risk prostate cancer, active surveillance {sa reasonable strategy because some men will never require treatment, and outcomes are no worse if men. ‘with low. grade cancer are treated at the time of progres: sion rather than when first diagnosed (see Item 38) Patients with prostate- specific antigen-only recurrence ‘of prostate cancer may be treated with androgen depri vation therapy, although observation is also a reasonable choice. + Patients with CT findings pathognomonic for renal cell, carcinoma do not need a biopsy to confirm the diagnosis. Chronic lymphocytic leukemia is typically an indolent dlisease, and many patients require no therapy for many years (see Item 49) Physical examination and PET/CT are used to stage patients with Hodgkin lymphoma; laparotomy and. splenectomy are no longer performed. * Chemotherapy without irradiation is a treatment option {or early-stage Hodgkin lymphoma after a complete‘metabolic response assessed by interim PET/CT after (wo to three cycles of treatment (risk-adapted therapy) (see Item 36). * Inpatients with a metastatic cancer of unknown primary site, CT and histologic, endoscopic, and gender-specific cancer evaluations are reasonable; however, nonspecific ‘tumor markers, PET, and gene expression arrays should not be done, * Palliative or hospice care is appropriate for patients with ‘an unfavorable subtype of cancer of unknown primary site who have comorbidities and poor performance status. ‘+ Nodal metastases are uncommon in thin melanomas (Breslow depth less than 0.8 mm) and need not be assessed ‘+ Most patients with neutropenic fever should be managed ‘with monotherapy with an antipseudomonal B-lactam agent. ‘+ There is no better therapeutic success but rather an Increased risk of toxicity from adding an aminoglycoside toa broad-spectrum B-lactam in the treatment of febrile neutropenia (see Item 33) + Growth factors are not routinely used in the treatment of patients with neutropenic fever unless the patient has severe neutropenia («100/iL [0.1 x 10/L]) expected to last more than 10 days o has other high-risk features, + Loop diuretics are not indicated in the treatment of hypercalcemia of malignancy unless kidney failure or heart fallure is present; in these circumstances, intrave- nous expansion of vascular volume should precede the administration of loop diuretics (see tem 43). * Spinal cord compression from radiosensitive tumor types, such as leukemia, Iymphoma, myeloma, and germ cell tumors, may not require initial surgical decompres- sion; instead, patients may be treated urgently with radi- ation therapy alone (see Item 63).Oncology Issues in Oncology Introduction Medical oncology is undergoing constant change and Improvement. Among the most important advances of the ppast decade has been the incorporation of immune check- point inhibitors into the standard treatment of many malig nancies. These agents, although not directly attacking the patient's cancer, deactivate checkpoints that would other wise suppress the immune system, and so facilitate the patient's own immune surveillance efforts to destroy the cancer. Another major advance includes the expanded role of molecular profiling and precision therapeutics. Current techniques allow for genomic profiling of tumor tissue, cither from fresh biopsies from archived, paraffin-embedded specimens, or from blood-based tumor mutation profiting, With the knowledge of the mutational profile, oncologists ‘can make more informed decisions in the selection and rejection of different therapeutic options and inclusion of so-called targeted therapies that are designed to Inhibit a particular molecular mutation or aberration. However, many traditional aspects of oncology, including the use of histologic diagnosis and clinical staging, as well as extensive use of cytotoxic chemotherapy, radiation therapy, and surgery, remain central to current oncologic practice. The cancer care continuum Is now recognized to include not only diagnosis and treatment but also supportive/palliative care, survivor ship care, and end-of-life care. Careful clinical evaluation and staging, understanding and communicating realistic goals of care, and recognizing ‘and promoting patient preferences remain central to the prac tice of oncology. Meaningful progress has been made in many types of cancer, However, most cancers, once metastasized, although treatable with substantial potential for improve ‘ments in overall survival and quality of life, are still incurable. Supportive management of adverse effects has also Improved: however, the adverse effects of cancer chemotherapy remain, problematic for many patients, and sensitivity t0 the risks ‘versus benefits must be considered when discussing treatment ‘options with patients. Burdensome increases in the cost of new oncology drugs has become a focus of concern, Some of these high-cost drugs are highly active and offer substantial benefits, whereas others result in survival advantages meas- tured in months or even weeks that, although statistically sig- rlficant, are of debatable clinical relevance. The impact of financial toxicity has become an important consideration in, ‘oncologic care. Staging To plan a treatment strategy a clinilan must fst determine thestage, or extent, ofthe cancer. arly stage cancersar often «aired by local therapy, such as surgery or tradiaton, whereas ‘more advanced-stage cancers require a systemic approach. Solld tumors are staged using the TNM system. In the TNM system, T(TI-T4) refers to thesize or extent of local invasion of the primary tumor, N (NO-N3) indicates locoreyional Iymph node involvement, and M indicates th absence (MO) or pres- ence (MI) of distant metastases. Some hematologle (liquid) tumors have unique tumor-specific staging systems. Approprtate Imaging techniques depend on the expected behavior pattern of each cancer type and differ from one tumor type to the next. Therefore, a proper cancer evaluation requites knowledge of the specific disease ently so that the necessary tests can be done and unnecessary tests avoided. “Tests with very low yield should not be ordered in te absence ‘of specific directing symptoms. For example, bone and brain Imaging 1s appropriate Inthe staging of patients with lung cancer because bone and braln metastases are common and ‘may be asymptomatic, However, in patients with presumed locoregional colorectal cancer, asymptomatic bone or brain ‘metastases are exceedingly rare; consequently routine imag- {ng of these sites is not warranted, Staging ina patient with cancer is generally the most accurate indicator of prognosis and largely dictates the therapeutic strategy REYES NTS ET ‘+ Most sold tumors are staged using the TM cancer staging system, In which T represents the siz or extent of local invasion ofthe primary tumor (T1-T4), N indicates locore- sional lymph node involvement (NO-N3), and M indicates the absence (MO) or presence (MI) of distant metastases. ‘Appropriate cancer-staging imaging techniques depend ‘on the expected behavior pattern of each cancer type; ‘therefore, proper cancer evaluation requires knowledge ‘of the specific disease entity so that the necessary tests ccan be done and unnecessary tests avoided, ‘+ Within a particular type of cancer, staging is generally the most accurate prognostic indicator and largely dic tates the therapeutic strategy. Performance Status Performance status is a means of quantifying how medically ‘At a patient Is. A good performance status predicts favorable 1Issues in Oncology {olerance and response to treatment. Patients with a poor per~ formance status are muuch more likely to experience serious oF life-threatening toxicity and much less likely to benefit from treatment. Is important to differentiate patients with a poor perfor: ‘mance status who are debilitated due to chronic comorbidities from patients who would otherwise be medically fit but are acutely debilitated by thelr cancer. The latter situation may ‘warrant an attempt at aggressive treatment because reversing the cancer is the only strategy that will improve the patient's ‘overall condition, whereas the former may need to be treated ‘with less aggressive treatment or possibly no specific antican- cer treatment. Cancer drug approvals are based on clinical trials, virtually all of which limit participants to patients with, ‘good performance status, so the degree to which the results of these trials are relevant to patients with poor performance status is limited, Age alone should not bea reason to avold aggressive treat- ‘ment. Elderly patients who are otherwise medically fit and healthy and have a good performance status may tolerate aggressive therapy well. ‘The two most commonly used performance status sales are the Karnofsky Performance Seale and the Fastern (Cooperative Oncology Group/ World Health Organization sys- tem (also called the Zubrod scale). These are outlined and contrasted in Table 1 POINT RITES + Patients with poor performance status may be divided into two groups: patients who are debilitated by chronic comorbidities and may need less aggressive treatment ‘and those who are debilitated by the cancer but are oth- cerwise medically fit and might benefit from aggressive treatment. + Most clinical trials used to determine treatment efficacy and safety are based on patients with good performance status; the results of such trials should generally not be expected in patients with poor performance status. Goals of Therapy Clear and candid communication between clinicians and pitients is essential for good oncologic are. When communt- cating treatment options and recommendations, clintians ‘must work to establish realistic treatment goals. When a cure {snot realistically possible, goals such as lengthening survival, shrinking a tumor, controlling disease growth, palliation or preventing disease-related symptoms, and maintaining qual- ity of fe should be discussed. The potential benefits of treat ‘ment must be weighed and considered against thetr risks and. toxicities. Patients with incurable eancer face choices of more aggressive therapy designed to prolong their life, associated ECOG/WHO Performance Status" (0- Fully active; no resticlions on actives 11-Unable to do strenuous atiitos, But able to carry outofice work, ight housework, or sedentary activites 2-Able towalk and manage self-care, but unable to work; outof bed or chair >50% of waking hours 3-Confined to bed or chair>50% of waking hours; capable of limited self-care | ‘4-Moribund. Fully confined toa bed or chair unable to do any self-care 5-Death Karnofzky Performance Status [7100-Normal: ne symptoms or evidence of disease 90- Minor symptoms, butable to caeryon normal activities | 80- Some symptoms; normal activity requires fort | 70- Unable to cary on normal activities, but able to care for self 40 - Disabled: needs special care and assistance 30- Severely disabled; hospitalized | 20-Veryil significant supportive care isneeded 10 Actively dying 0-Death {60- Needs frequent care for most noeds; some occasional assistance with cocare 50- Needs considerable assistance with self-care and frequent medical carewith more unpleasant and potentially dangerous adverse effects. Similarly, more aggressive initial therapy may result in prolonged remission or disease-free survival but may not nec- essarily change overall survival. All patients will have a unique perspective on how they interpret this equation. ‘A cancer diagnosis has been shown to be a leading cause of personal bankruptcy, and studies show financial worries contribute to patients’ anxiety. Inability to meet copays or cotn- surance requirements, especially for expensive oral anticancer ‘medications, is a leading cause of failure to properly receive ‘therapy: A clear understanding ofthe goals of care and the tox ies, including financial toxicity, is necessary for patients and physicians to make informed choices in treatment options. This, concept of financial toxicity goes beyond individual patients in affecting the overall health care economy. Quantifying the ‘overall benefit of extending a patients life by relatwely short periods (less than 2 months’ median benefit) and contrasting ‘that benefit by the financial cost of care require complex ethi- cal, economic, and public health decisions. Early-stage cancers often havea high chance of cure. With ‘nereasing cancer stage, the possibility of cure diminishes. Most ‘metastatic cancers are treatable but not curable. The risks of treatment are higher and may outweigh the benefit in patients, ‘with poor performance status due to chronie medical comor- bldities or those who have not been able to tolerate initial treat- ‘ment attempts, For such patients or for those who have cechausted standard treatment options, supportive, comfort- oriented care may be most appropriate, Use of adequate anal- fgesia, as well as involving supportive care specialist, is Important throughout the continuum of care but particularly, so in patients with pain or with symptoms from either disease ‘or therapy, Studies suggest that such supportive care, when instituted early in conjunction with anticancer therapy, helps patients better tolerate their cancer care and should not be delayed to the point at which no more active cancer therapy is, considered. RINSE ‘© The potential benefits of treatment must be weighed and discussed along with its risks and toxicities, includ~ ing financial toxicity, because the costs of anticancer treatments have increased substantially ‘Palliative care shouldbe instituted early in the manage- ‘ment of patients with cancer and not reserved only for the ‘time when they are no longer receiving cancer therapy. Understanding Cancer Terminology ‘A clear understanding of cancer terminology is necessary to foelitate informed discussions and develop realistic treatment souls. ‘The one pure and simple term Is cure. Cure means that the cancer is gone, no further treatment is required, and the patient can be expected to live out his or her life without Issues in Oncology seeing that cancer again. Cure should not be confused with the term overall survival, which is defined as the amount of time from the start of treatment until death. Overall survival soften, misunderstood by patients to be synonymous with cure. ‘Median survival outcomes that are reported in studies are too often explained to patlents as indicating how long they will live, but it must be understood and explained that medians ‘dentify the center of an often-broad, bell-shaped curve, and ‘may be meaningful for populations, but cannot predict an ‘outcome for any one individual patient, Patient expectations can be further confused by the frequent use of the phrase significant improvement in sur vival, in which significant refers to the statistical certainty of the finding but is often misinterpreted as a substantial improvement in survival. Many drugs have been approved with significant improvements in median survival that are limited to less than 2 or 3 months, a quantity that most ‘would agree is not substantial. Furthermore, one must be ‘cautious about interpreting nonrandomized comparisons of folder versus newer survival data. Randomized controlled trials are the only reliable means of comparing one treat- ‘ment with another. One of the most misrepresented and misunderstood terms is progression-free survival. Itis the time from when a treatment is started until that treatment is no longer control ling the cancer. The word survival was initially included in the term because the duration of progression-free survival is, defined by either growth ofthe cancer (progression) or patient
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