Patient had history of malignant colon cancer in 2019. Patient underwent right hemicolectomy on February 20, 2019. Initial pathology report from that colon cancer indicated it adenocarcinoma, invasive, intermediate grade. Pathologic evaluation was stage II, T3N0 and oncology recommended clinical monitoring only and patient continuously followed oncology as recommended from February 2019 to present.
On October 20, 2021 the patient underwent a CT Chest and CT Abdomen and Pelvis with contrast. The CT Abdomen and Pelvis revealed there was a "new hypodense lesion within segment 5 of the liver measuring 4.8 x 4.1 cm consistent with metastatic disease."
The patient was never notified of this finding by anyone including oncology and when she saw her oncologist on April 12, 2022 the physician never mentioned this finding and only noted in the record that "CT of the abdomen and pelvis with contrast on February 5, 2019 revealed no evidence of distant metastasis."
Based on blood work the patient's PCP recommended an abdominal ultrasound, which she underwent on July 1, 2022. It revealed a dominant lesion with smaller multiple lesions in the liver, 10.0x8.4x10.1 cm in aggregate. Findings were suspicious for liver metastases.
Thereafter, the patient underwent a CT Abdomen and Pelvis on July 15, 2022, which revealed very large heterogeneous low-density irregular lesion throughout the right lobe of the liver measuring 12.5x9.4x9 cm most concerning for metastatic disease. Smaller satellite lesions were noted.
On July 21, 2022 the patient underwent ultrasound guided biopsy and results were adenocarcinoma, most consistent with metastatic colon adenocarcinoma. Tumor was positive for CK2O and CDX2, and Negative for TTF-1, CK7 AND GATA-3.
The patient consulted a surgeon, and was told that, had the lesion been diagnosed in October 2021, when it was isolated and 4.8 cm in max diameter, resection would have been possible. However, given the presence of multiple new liver lesions as well as the increase in size of the dominant mass, surgery was no longer a consideration at the present time.
Thereafter, the patient was started on chemotherapy.
Do you believe that the patient's prognosis was affected by the delay in diagnosis and by the missed window of opportunity for resection?
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Do you believe there might have been medical error?
This was a 80yo woman with stage 2 CRC. According to the NCCN guidelines, the standard of care in the USA is the following: • History and physical examination every 3–6 mo for 2 y, then every 6 mo for a total of 5 y • CEA every 3–6 mo for 2 y, then every 6 mo for a total of 5 y • Chest/abdominal/pelvic CT every 6–12 mo (category 2B for frequency <12 mo) from date of surgery for a total of 5 y • Colonoscopy in 1 y after surgery except if no preoperative colonoscopy due to obstructing lesion, colonoscopy in 3–6 mo If advanced adenoma, repeat in 1 y If no advanced adenoma repeat in 3 y, then every 5 y The physician deviated from the standard of care by not getting a CT scan every 6 - 12 months as the guidelines recommend. Thus, the first metastatic lesion was missed.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The medical error, as stated above, was the failure to follow national guidelines for the surveillance for CRC after initial diagnosis of stage 2 disease. The oligometastatic disease identified may have been treated by local resection or radiotherapy or chemo-embolization, for example. However, the metastatic lesion was missed by lack of appropriate surveillance in this case and contributed to the delay in diagnosis of mCRC.
What makes you a good expert for this case?
I am a board certified medical oncologist and graduated from Columbia University in 2013 (10+ years experience as a medical oncologist)
How often do you encounter cases similar to this one in your practice?
this is very common, unfortunately, in community practices.
Do you believe there might have been medical error?
It is unclear from this summary who ordered the CT scan in the fall of 2021, though it is likely to be the oncologist. NCCN guidlines recommend CT imaging every 6 to 12 months for 5 years after surgery for stage II colorectal cancer, so the oncologist, even if he/she did not order the scan, should be keeping track of the patient's follow-up imaging. If the patient had an advanced imaging study, then the report should have been tracked down to verify the results. There does seem to have been either physician error or lack of effort or a systems error in this case, or a combination of all three. . Modern electronic records systems have their quirks that can befuddle patient care. If there is a direct electronic connection between the oncology EMR and the hospital where the study was done, the result may be imported electronically with no notification to the physician. Before EMRs, reports often came by fax and results placed on the physician's desk. Often support staff would read the impression and alert the physician to an abnormal finding. Finally, this patient is 80 and there can be either subtle or overt discrimination against the elderly in cancer care. Some see those over 80 as inappropriate for chemotherapy or surgery and so surveillance is not pursued with as much vigor as in younger patients. I disagree with this approach, but it all depends on the patient's overall physical and cognitive function.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
This is a closer call. Most oncologists accept the idea that early treatment is better for metastatic colon cancer than waiting until symptoms develop. This has not been proven in the era of modern chemotherapy. Early studies of initial treatment with 5-FU/leucovorin versus a watch and wait approach showed a 5-6 month improvement in survival. A recent retrospective study from Australia using more modern chemotherapy suggests a similar benefit. In this case, there was the potential for surgery. However, for this potential to have been realized, the patient would have to be medically fit for surgery and she would have to be anatomically appropriate. Liver resection is often uncomplicated, but the lesion must be towards the edge of the liver where it can be easily removed. At 80 she would not have been a good candidate for a heroic and complicated operation on a lesion deep in the liver. Even if unresectable, she may have been a candidate for chemotherapy and destructive treatments such as radiofrequency ablation or stereotactic body radiosurgery. However, the survival benefits of these approaches are less proven.
What makes you a good expert for this case?
I have 30 years of clinical experience in managing patients with complicated medical problems. I am always aggressive when there is a chance for cure or long term survival, but carefully to evaluate patients for hospice care in situations where they are not responding or their quality of life is poor. I have a keen eye for the vagaries of and errors of medical documentation. I have a written a rough draft of a book on the topic. I also have written a rough draft of a book containing a collection of cases of elderly patients with cancer and the decisions that physicians and patients face at those times. I have evaluate nearly 100 cases in the past 5 years for medical malpractice, workman's compensation claims, and insurance coverage decisions. However, I still practice oncology 4 days a week.
How often do you encounter cases similar to this one in your practice?
Every 1-3 months, in different formats - colorectal, rectal, other diseases, young or old. I always make sure I have all the data, I am skeptical of vague reports or uncertainties because I never want to miss a chance to give the patient extended survival.
Do you believe there might have been medical error?
Clearly, the October 2021 scan was abnormal and was not followed up on. She should’ve been contacted to work this up in October. KARAN colleges, in April 2022 also did not note the recent scan and its abnormality. Both of these are errors. Potentially, she could’ve had the scans at an outside organization, and didn’t let the doctor know that this was done. That would be a mitigating factor, if the oncologist had no way of knowing that she had that scan.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
It appears that there was a delay of about nine months, from time of abnormal scan in October 21, till definitive work up was begun on July 2022. Clearly the tumor had grown by the time they performed the biopsy, making the disease burden, greater, likelihood for response less, and may have caused harm. Technically speaking, it appeared that she had potentially resectable disease at the initial CT, if there was no other disease, and her performance status would allow it. I have no details on her status, work up, such as pet, scan, or other sites of disease. clearly by July, this was unresectable, and only systemic therapy with chemotherapy would be considered at that time. She may have lost a window for potential resection. Again, I can think of potential mitigating circumstances, if patient had comorbidities, or was frail, and or she stated she did not want any work up earlier in her course.
What makes you a good expert for this case?
I am a medical oncologist with about 30 years experience, who sees many people with metastatic colon cancer.
How often do you encounter cases similar to this one in your practice?
I often see patients with colon cancer, both early stage, or localized, and patients with metastatic disease, whether they present at the time of diagnosis with Metz, or recurrence later. Also, much of my population is geriatric, and large part of seeing colon cancer patients is deciding what type of therapy to give them and when
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