what is a complete response in cancer treatment

What does a complete response to cancer mean?

Kelli, I have first hand experience with a complete response to presurgical chemoradiation, although as some people here have already stated, you can't be sure there was a complete response until after the pathology report. In any event, your news is all good. I am here alive and well more than 5 years after my diagnosis with stage 3 rectal cancer.

What is complete response to treatment (CR)?

complete response (kum-PLEET reh-SPONTS) The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Search NCI's Dictionary of Cancer Terms Starts with Contains Browse: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #

What is the difference between a complete response and a cure?

 · When a treatment completely gets rid of all tumors that were seen on a test or were measured in some way, it’s called a complete response or complete remission. A complete response or complete remission does not mean the cancer has been cured, only that it can no longer be seen on tests. Partial remission. In general, a partial response (or partial remission) …

What does a complete response or complete remission mean?

 · Complete response. Complete response (CR) is defined as the lack of detectable evidence of tumor . Imaging studies and histopathology are used to measure CR which can be used as a surrogate or primary endpoint depending on the specific disease or context of use .

What does complete response to chemo mean?

Complete response to treatment (CR) is the term used for the absence of all detectable cancer after your treatment is complete. Complete response doesn't necessarily mean that you are cured, but it is the best result that can be reported. It means the cancerous tumor is now gone and there is no evidence of disease.

What is the response to cancer treatment?

Response to cancer treatment is defined several ways: Complete response - all of the cancer or tumor disappears; there is no evidence of disease. A tumor marker (if applicable) may fall within the normal range. Partial response - the cancer has shrunk by a percentage but disease remains.

What is complete response rate in cancer?

A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the overall response rate is one way to see how well a new treatment works.

What does complete clinical response mean?

Complete clinical response is defined as an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy.

What is the difference between remission and complete response?

Cancer remissions are often classified as either “partial” or “complete.” A partial remission or partial response signifies a reduction of at least 30% of a measurable tumor within the body. By contrast, a complete remission or complete response indicates all detectable evidence of cancer is gone.

What is complete remission?

Remission means that the signs and symptoms of your cancer are reduced. Remission can be partial or complete. In a complete remission, all signs and symptoms of cancer have disappeared. If you remain in complete remission for 5 years or more, some doctors may say that you are cured.

How is complete response measured?

A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.

What does overall response mean?

Overall response rate, or ORR, is the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug.

What is best overall response rate?

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).

What is duration of response?

Duration of response is the time from response (R) to progression/death (P/D). The existing statistical procedures for DOR are valid when certain model assumptions are correctly specified. 3. Therefore, in a typical report of a clinical study, DOR is summarized descriptively.

What does no residual carcinoma mean?

Treatment effect If no cancer is found after neoadjuvant treatment, the pathologist will say no residual carcinoma.

How is overall survival measured?

The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.

How do most people respond to chemo?

Chemotherapy Is an Individual Experience Whatever you experience, remember there is no relationship between how the chemotherapy makes you feel and whether you derive benefit from it. Many people feel fine for the first few hours following chemotherapy. Usually, some reaction occurs about four to six hours later.

How do you assess response to chemotherapy?

Currently, treatment responses are assessed on the basis of measurement of tumor size before and after treatment with serial conventional radiography, such as chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) (2).

Why do some people not respond to cancer treatment?

Why do some people respond to a cancer therapy and some do not? While cancer is a genetic disease, response to therapy is not as systematic or clear-cut as simply matching a mutation to treatment.

Why do some people respond better to chemo?

MIT researchers have shown that cells from different people don't all react the same way when exposed to the same DNA-damaging agent -- a finding that could help clinicians predict how patients will respond to chemotherapy.

What is a durable response to cancer treatment?

There is not a standardized definition, but it usually refers to a response to treatment that is much longer than expected for a metastatic (stage 4) solid tumor (such as lung cancer, breast cancer, etc.)

What is the difference between a durable response and a remission?

Many people wonder what the difference is between a durable response and remission. Remission can be either complete (no evidence of tumor) or partial (a 30% or greater decrease in size of a tumor). The cancer does not have to be completely gone to qualify as a durable response.

What is the closest thing we have to a cure for cancer?

Predictors of a Durable Response. Since achieving a durable response is the closest thing we currently have to a "cure" for most advanced cancers, researchers have been looking for ways to determine who is likely to have a durable response when treated with immunotherapy.

Can a tumor grow back after stopping treatment?

Most often, if medications such as targeted therapies are stopped, a cancer begins to grow again, even if it appeared to be in complete remission. In contrast, it's now not uncommon for an advanced solid tumor to stay in remission after checkpoint inhibitors are stopped.

Can immunotherapy cause hyperprogression?

In contrast to normal progression (the progression of a cancer that's expected if it does not respond to a treatment), hyperprogression with immunotherapy may uncommonly occur.

Can cancer recur after a durable response?

There are some problems in this theory that may lead to a recurrence of a cancer even after a durable response occurs. Cancer cells are continually developing new mutations, including resistance mutations that allow them to escape cancer treatments or detection by the immune system.

Does the immune system recognize cancer cells?

Since the immune system can (albeit in the minority of patients) better recognize cancer cells after treatment, it makes sense that it would continue to work even after the medications are discontinued. In fact, the rare occurrence of the spontaneous remission of cancer is thought to work in this way. There are some problems in this theory that may ...

What is partial response?

In general, a partial response (or partial remission) means the cancer responded to treatment, but still has not gone away. A partial response is most often defined as at least a 50% reduction in measurable tumor. (If you’re in a clinical trial, response is usually defined very precisely.) The reduction in tumor size must last for at least a month to qualify as a response. Again, you can ask for more details about the kind of response to treatment the doctor sees, and how long it lasts.

How long does it take for cancer to come back?

But most doctors consider recurrence to be cancer that comes back after you’ve had no signs of it for at least a year.

What is it called when a tumor is completely removed?

When a treatment completely gets rid of all tumors that were seen on a test or were measured in some way, it’s called a complete response or complete remission . A complete response or complete remission does not mean the cancer has been cured, only that it can no longer be seen on tests.

Can cancer cells grow again?

This means chemotherapy or radiation may have killed most of the cancer cells, but some of them were either not affected or changed enough to survive the treatment. These cancer cells can then grow and show up again.

What does it mean when a doctor says a tumor is still there?

A doctor may use the term “controlled” if your tests or scans show that the cancer is still there, but it’s not changing over time. Controlled means that the tumor doesn’t appear to be growing. Another way of defining control would be calling the disease stable. Some tumors can stay the same for a long time, even without any treatment. Some stay the same size after cancer treatment and are watched to be sure that they don’t start growing again.

What does it mean when cancer comes back?

Local recurrence means that the cancer has come back in the same place it first started.

Do cancers recur?

Most types of cancer recur in a typical pattern – your cancer care team can tell you more about this if it’s something you’d like to know.

What is the primary endpoint of a clinical trial?

For example, a primary endpoint in oncological clinical trials is usually survival: a direct, measurable outcome based on the drug’s expected effects. A secondary endpoint, such as quality of life, may be chosen to explore additional benefit the patient may gain including functional and emotional status.

What is TTP in cancer?

Time to progression (TTP) is defined as the time from randomization until first evidence of disease progression [15]. Since PFS and TTP are similar, it is important for studies to clarify what is meant by evidence of disease progression. In advanced breast cancer, some investigators use PFS and TTP interchangeably, potentially leading to confusion when comparing the outcomes of various trials [17]. Meanwhile, studies have used TTP to evaluate aggressive therapies for advanced non-small cell lung cancer, however, its use as a surrogate marker is not definitive and it should be avoided as a primary endpoint [18]. The value of TTP’s assessment has the potential to be adversely affected by disease characteristics unique to each patient including inter-tumor variation and the tumor’s natural growth rate. In response, researchers have proposed a patient-personalized “TTP ratio” as an additional parameter to measure the effectiveness of targeted therapy [19]. This variant of TTP compares tumor growth both on and off treatment, serving as an intra-patient control for natural tumor growth rate [19].

What is the duration of clinical benefit?

Duration of clinical benefit (DoCB) is defined as the time from randomization to disease progression or death in patients who achieve complete response, partial response, or stable disease for 24 weeks or longer [32]. It is a primary endpoint that is used in clinical trials in which disease stabilization in order to prolong survival is the primary goal.

What is TTNT in medical terms?

Time to next treatment (TTNT) is defined as the time from initiating treatment to initiating the next line of therapy [30]. In low grade, incurable diseases, TTNT is a meaningful endpoint for patients who will require many therapeutic interventions to extend survival. Unlike most disease-related endpoints, TTNT includes the time course of treatment tolerability and patient compliance [30]. TTNT continues to emerge as a measure of duration of treatment efficacy, specifically in primary cutaneous T-cell lymphomas [31]. Despite its usefulness, TTNT is a surrogate marker for duration of clinical benefit and requires validation before serving as a standalone marker to assess treatment efficacy.

What is the overall survival of a patient?

Overall survival (OS) is defined as the time from randomization to death [10]. Any patients lost to follow up or still alive at the time of evaluation are censored [11]. Since the goal of cancer treatment is generally to extend survival, OS is often referred to as the gold standard endpoint in oncology clinical trials [6]. OS is a patient- centered endpoint that is easy to measure; it is definite since the final time point is death [12]. Moreover, OS is objective, and researcher bias is unlikely to take place [13,14]. While OS remains the preferred clinical endpoint in oncology clinical trials, it has some drawbacks. Primarily, the expectation of long-term patient follow-up indicates a larger patient population is required and the study will require more financial support [15]. Additionally, OS has limited use in diseases that are slowly progressing and have an expected long-term survival. In these cases, OS may be influenced by treatment in further steps, sequential use of other agents, and cross-over treatments, making it difficult to attribute the clinical endpoint to a specific medical intervention [4]. Additionally, as a primary clinical endpoint, OS can also be influenced by non-cancer deaths since the endpoint is defined as time from randomization to death of any cause [10].

What are the qualities of a good primary clinical endpoint?

There are many qualities a good primary clinical endpoint should have. Endpoints should be easy to measure either objectively or subjectively by a clinician, observer, or patient [2]. Most importantly, a primary clinical endpoint should have clinical relevance to the patient and directly measure a patient’s feelings, ability to perform daily tasks, or survival [3]. Since choosing the wrong endpoint can make it difficult to detect study outcomes, many trials utilize numerous endpoints which may have primary or secondary significance [4]. Clinical trials also frequently rely on the utilization of surrogate endpoints to substitute for clinical endpoints [5]. In the classical definition of surrogate endpoints, they are referred to as “biomarkers”, however, not all biomarkers will meet the criteria to be surrogate endpoints [6]. In order for a biomarker to be considered a surrogate endpoint, there must be a relationship between the biomarker and the clinical outcome; a mere association between the biomarker and the pathophysiology of the disease is not sufficient [6]. If general information about the disease pathophysiology and the intervention’s mechanism of action, surrogate endpoints are expected to predict clinical benefit or harm [6]. While surrogate endpoints have historically been used to rapidly assess medical interventions in clinical trials, they do not have strict validation criteria [6]. Alternatively, there exists a set of guidelines that provides a framework for understanding the evidence surrogate endpoints provide in a study [7].

Why are endpoints important in clinical trials?

Since medical interventions can have a number of effects on a patient, it is important to use multiple endpoints to assess changes in clinical course that occur as a result of the intervention [1]. Additionally, the use of multiple endpoints allows a team to evaluate outcomes that will arise independently of intervention or that will be modified by intervention [1]. While non-clinical endpoints, such as biomarkers, are frequently utilized as objective measures of biological processes, their use falls outside of the scope of this paper in which we will focus on clinical and surrogate endpoints. There are different ways to categorize clinical endpoints depending on the trial goals and objectives. Generally, clinical endpoints can be classified as primary, secondary, or tertiary depending on their relevance to the main research question. While primary endpoints are efficacy measures that address the question directly, secondary and tertiary endpoints may be utilized to demonstrate additional effects, support a mechanism of action, or explore less frequently occurring outcomes [1]. For example, a primary endpoint in oncological clinical trials is usually survival: a direct, measurable outcome based on the drug’s expected effects. A secondary endpoint, such as quality of life, may be chosen to explore additional benefit the patient may gain including functional and emotional status. All other exploratory endpoints would be classified as tertiary endpoints.

What is complete response in cancer?

A complete response differs from a cure in that microscopic amounts of tumor the may remain in the patient and later produce a relapse.

When does the FDA send a response letter?

It is the FDA's practice to send complete response letters to sponsors of new drug applications when there are concerns about whether the drug should be approved and to outline information needed to complete the approval process.

What is the CRL for Sarepta?

Sarepta Therapeutics announced it had received a Complete Response Letter, or CRL, from the FDA regarding the New Drug Application seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy ) in patients with a confirmed mutation amenable to exon 53 skipping.

How many responses does Rituximab have?

Neelapu said that Rituximab treatment alone usually achieves a 40 percent overall response rate and about 11 percent complete responses, asserting that the side effect profile of the combination is about the same as rituximab alone.

How long does it take for intestinal metaplasia to be eradicated?

Among patients with high-grade dysplasia at baseline, 83% retained complete response (complete eradication of intestinal metaplasia) at 2 years in the intent-to-treat analysis; 88% did so in the per-protocol analysis.

Does Triplet improve complete response rates?

The addition of anti-PD-L1, anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to a single dose of the Triplet improved complete response rates over either mRNA or antibody treatment alone.

What does it mean when cancer is progressing?

Progression means your cancer has grown or spread. You may need to switch treatments to control it.

What happens after cancer diagnosis?

After you're diagnosed with cancer, your doctor will choose treatments that have the best chance of curing your disease. But everyone is different. So how will your doctor track how well your treatment works?

What are the signs of cancer?

Pain in your bones or joints, or broken bones -- signs that the cancer has spread to your bones. Headaches, seizures, dizziness, confusion, or vision changes -- signs that the cancer has spread to your brain.

What is the term for the area where a surgeon takes out the tissue around a tumor?

This is called the margin . The surgeon may also remove some lymph nodes near the cancer.

How long does it take for cancer to die after radiation?

Surgery removes all or most of the cancer at one time, but it can take weeks or months after you get radiation for all of the cancer cells to die. Everyone responds differently to cancer treatment, but your doctor will make every effort to get rid of as many cancer cells as possible.

What is the test that shows cancer on a breast?

If your treatment is working, there should be fewer highlighted areas on the picture. Mammogram. This test uses low-energy X-rays to look for cancer in the breasts.

What is the best way to find out if you have cancer?

MRI, or magnetic resonance imaging. An MRI uses powerful magnets and radio waves to make pictures of your organs and other structures. It can show where the cancer is in your body. PET, or positron emission tomography. In this test, you get a radioactive substance that cancer cells in your body absorb.

What is the best response to a tumor?

Table ​Table11shows a brief comparison of WHO, RECIST v1.0 and RECIST v1.1 criteria[5,6,8,11,12]. The best overall response is a result of a combination of tumor responses in target and nontarget lesions. If there is any new lesion, the overall best response is always PD. In the absence of any new lesion, CR is the complete disappearance of all target and nontarget lesions. No change in nontarget lesions reduces a CR in target lesions to an overall PR, but no change in nontarget lesions does not reduce a PR in target lesions.

What is tumor objective response rate?

The tumor objective response rate (ORR) is an important parameter to demonstrate the efficacy of a treatment in oncology. The ORR is valuable for clinical decision making in routine practice and a significant end-point for reporting the results of clinical trials. World Health Organization and Response Evaluation Criteria in Solid Tumors (RECIST) are anatomic response criteria developed mainly for cytotoxic chemotherapy. These criteria are based on the visual assessment of tumor size in morphological images provided by computed tomography (CT) or magnetic resonance imaging. Anatomic response criteria may not be optimal for biologic agents, some disease sites, and some regional therapies. Consequently, modifications of RECIST, Choi criteria and Morphologic response criteria were developed based on the concept of the evaluation of viable tumors. Despite its limitations, RECIST v1.1 is validated in prospective studies, is widely accepted by regulatory agencies and has recently shown good performance for targeted cancer agents. Finally, some alternatives of RECIST were developed as immune-specific response criteria for checkpoint inhibitors. Immune RECIST criteria are based essentially on defining true progressive disease after a confirmatory imaging. Some graphical methods may be useful to show longitudinal change in the tumor burden over time. Tumor tissue is a tridimensional heterogenous mass, and tumor shrinkage is not always symmetrical; thus, metabolic response assessments using positron emission tomography (PET) or PET/CT may reflect the viability of cancer cells or functional changes evolving after anticancer treatments. The metabolic response can show the benefit of a treatment earlier than anatomic shrinkage, possibly preventing delays in drug approval. Computer-assisted automated volumetric assessments, quantitative multimodality imaging in radiology, new tracers in nuclear medicine and finally artificial intelligence have great potential in future evaluations.

How much increase in enhanced tumor volume?

At least 73% increase in the enhanced tumor volume

How much decrease in the sum of max. diameters of the enhanced tumor area?

At least 30% decrease in the sum of max. diameters of the enhanced tumor area

Is tumor shrinkage always symmetrical?

Tumor shrinkage is not always symmetrical; tumors have heterogenous changes due to necrosis, fibrosis or intratumoral hemorrhage, especially after locoregional therapies or biologic agents[24]. The new proposed criterion, quantitative EASL (qEASL), is the 3-dimensional volumetric assessment of enhancing tumor tissue[25]. Table ​Table22shows a comparison of mRECIST for HCC, EASL and qEASL[18,22-25]. qEASL predicted survival better than RECIST, mRECIST and EASL criteria in patients with HCC[24].

What is the WHO response criteria?

For more than two decades, the WHO response criteria were used as the standard method for tumor evaluation. Due to the development of some problems such as the interobserver variability of the number of lesions, selection of measurable targets, minimum lesion size and definition of PD, WHO criteria became no longer comparable among research organizations[7]. Measuring all lesions was also a time-consuming procedure and carried the risk of measurement errors. Next, to standardize and simplify the methodology, the RECIST version 1.0 was proposed as a new guideline to evaluate the response in 2000[8]. The arrival of new technologies such as computed tomography (CT) and MRI has also led to some new definitions of measurable lesions. RECIST v1.0 criteria brought the term of “target” and “nontarget” lesions. Target lesions are selected based on their size (from those with the longest diameter to shortest ones), are representative lesions of all involved organs, and they should be reproducible by repeated measurements. According to RECIST v1.0, all measurable disease up to a maximum of 5 lesions per organ and 10 lesions in total were representative of all involved organs and should be identified and recorded as target lesions at baseline. All other lesions were nontarget lesions. The RECIST v1.0 guideline was revised in 2009; the maximum number of target lesions per organ was reduced from 5 to 2, and 10 to 5 in total, in RECIST version 1.1[11]. Assessment of the pathological lymph nodes was incorporated as well; nodes with a short axis ≥ 15 mm were considered measurable, pathological and assessable as target lesions. Lymph nodes with a short axis < 10 mm were considered normal. Lymph nodes with a short axis between 10 and 15 mm were included as nonmeasurable nontarget lesions.

What are the WHO criteria?

According to the WHO criteria, the tumor size reflects its surface and is determined by bidimensional measurements and multiplication of the longest diameter by the greatest perpendicular diameter for single lesions . The total tumor load of a patient is the sum of the products of the perpendicular diameters for multiple lesions. The objective response to treatment is divided into four categories: Complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) (Table ​(Table11).

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